Kit for forming implants in wall of gastrointestinal tract

ABSTRACT

An apparatus comprising an elongate probe member having proximal and distal extremities for use with a suction source to treat a portion of a wall forming a cavity in a body having a natural body opening for accessing the cavity. The elongate probe member has a length so that when the distal extremity is in the vicinity of the portion of the wall the proximal extremity is outside of the body. The distal extremity of the elongate probe member has an outer surface and is provided with at least one recess opening onto the outer surface and an internal passageway communicating with the recess. When the suction source is coupled to the apparatus a suction is created in the recess by means of the passageway to draw the portion of the wall into the recess. A hollow needle is slidably disposed in the elongate probe member and has a distal end portion. The needle is actuatable from outside the body for movement from a retracted position in which the distal end portion of the needle is out of the recess and an extended position in which the distal end portion of the needle extends into the recess. The needle can be extended into the portion of the wall drawn into the recess so as to introduce a material into the portion of the wall and form an implant in the portion of the wall.

CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims priority to U.S. provisional patentapplication Ser. No. 60/148,838 filed Aug. 13, 1999, the entire contentof which is incorporated herein by this reference.

BACKGROUND OF THE INVENTION

[0002] 1. Field of the Invention

[0003] This invention pertains to the treatment of a portion of a wallforming a cavity in a body.

[0004] More particularly, this invention pertains to an apparatus forforming implants in a portion of the wall forming the gastrointestinaltract.

[0005] 2. Description of Related Art

[0006] Gastroesophageal reflux disease (GERD) is a failure of theanti-reflux barrier, allowing abnormal reflux of gastric contents intothe esophagus of the gastrointestinal tract.

[0007] Gastroesophageal reflux disease is a disorder which is usuallycharacterized by a defective lower esophageal sphincter (LES), a gastricemptying disorder with or without failed esophageal peristalsis. Thedisease usually manifests itself during “transient lower esophagealsphincter relaxation” episodes, the frequency of which is greatlyincreased in patients who reflux. Medical or drug therapy is the firstline of management for gastroesophageal refluxes. However, drugmanagement does not address the condition's mechanical etiology. Thussymptoms recur in a significant number of sufferers within one year ofdrug withdrawal. In addition, while medical therapy may effectivelytreat the acid-induced symptoms of gastroesophageal reflux disease,esophageal mucosal injury may continue due to ongoing alkaline reflux.Since gastroesophageal reflux disease is a chronic condition, medicaltherapy involving acid suppression and/or promotility agents may berequired for the rest of a patient's life.

[0008] The expense and psychological burden of a lifetime of medicationdependence, undesirable life style changes, uncertainty as to the longterm effects of some newer medications and the potential for persistentmucosal changes despite symptomatic control, all make surgical treatmentof gastroesophageal reflux disease an attractive option. Unfortunately,surgical intervention is a major operation with all attendantmorbidities, mortality and risk of failure requiring further surgery inthe case of over-correction. Laparoscopic surgery requires a very highlevel of skill and special training for it to be successful.

[0009] Minimally invasive procedures have been provided for formingimplants in the wall of the gastrointestinal tract to treat GERD andother ailments. It would be desirable to have a method and device forforming implants of a predetermined size in a consistent manner toenhance the reproducability of such procedures.

OBJECTS AND SUMMARY OF THE INVENTION

[0010] In general, it is an object of the present invention to provide aminimally invasive apparatus for injecting a material into a portion ofa wall forming a cavity in a body, such as the gastrointestinal tract,to form one or more implants of a substantially consistent size in thewall.

[0011] Another object of the invention is to provide an apparatus of theabove character in which a recess in a probe is utilized to shape theportion of the wall into a protrusion into which the material isinjected.

[0012] Another object of the present invention is to provide anapparatus of the above character in which the probe guides and positionsan injection needle into the protrusion.

[0013] Another object of the present invention is to provide anapparatus of the above character in which consistently sized multipleimplants may be formed in a portion of the wall of the cavity.

[0014] Another object of the present invention is to provide anapparatus of the above character which can inhibit the injection needfrom being pushed through the wall.

[0015] Another object of the present invention is to provide anapparatus of the above character which can be used for treatinggastroesophageal reflux disease (GERD).

[0016] In general, an apparatus comprising an elongate probe memberhaving proximal and distal extremities has been provided for use with asuction source to treat a portion of a wall forming a cavity in a bodyhaving a natural body opening for accessing the cavity. The elongateprobe member has a length so that when the distal extremity is in thevicinity of the portion of the wall the proximal extremity is outside ofthe body. The distal extremity of the elongate probe member has an outersurface and is provided with at least one recess opening onto the outersurface and an internal passageway communicating with the recess. Whenthe suction source is coupled to the apparatus a suction is created inthe recess by means of the passageway to draw the portion of the wallinto the recess. A hollow needle is slidably disposed in the elongateprobe member and has a distal end portion. The needle is actuatable fromoutside the body for movement from a retracted position in which thedistal end portion of the needle is out of the recess and an extendedposition in which the distal end portion of the needle extends into therecess. The needle can be extended into the portion of the wall drawninto the recess so as to introduce a material into the portion of thewall and form an implant in the portion of the wall.

BRIEF DESCRIPTION OF THE DRAWINGS

[0017]FIG. 1 is a perspective view of an apparatus for treating aportion of a wall forming a cavity in a body in accordance with thepresent invention.

[0018]FIG. 2 is a cross-sectional view of the apparatus of FIG. 1 takenalong line 2-2 of FIG. 1.

[0019]FIG. 3 is a cross-sectional view of a portion of the apparatus ofFIG. 1 taken along line 3-3 of FIG. 1.

[0020]FIG. 4 is an enlarged side view of a portion of the apparatus ofFIG. 3.

[0021]FIG. 5 is a cross-sectional view of a proximal portion of theapparatus of FIG. 1 taken along the line 5-5 of FIG. 1.

[0022]FIG. 6 is an elevational view of the apparatus of FIG. 1 treatinga lower esophageal sphincter in accordance with the present invention.

[0023]FIG. 7 is a cross-sectional view of the lower esophageal sphincterof FIG. 6 at the level of the gastric cardia taken along the line 7-7 ofFIG. 6.

[0024]FIG. 8 is a perspective view of another embodiment of a portion ofthe apparatus of the present invention.

[0025]FIG. 9 is an enlarged perspective view, broken apart, of thedistal end of the apparatus of FIG. 8.

[0026]FIG. 10 is a cross-sectional view of the apparatus of FIG. 8 takenalong the line 10-10 of FIG. 8.

[0027]FIG. 11 is an enlarged perspective view of the distal portion ofthe apparatus of FIG. 8.

[0028]FIG. 12 is a schematic view of a plurality of needles for use inthe apparatus of FIG. 8.

[0029]FIG. 13 is a cross-sectional view, similar to FIG. 10, of afurther embodiment of the apparatus of the present invention.

[0030]FIG. 14 is an enlarged perspective view, similar to FIG. 11, ofthe distal portion of the apparatus of FIG. 13.

[0031]FIG. 15 is a cross-sectional view of the distal portion of yetanother embodiment of the apparatus of the present invention.

[0032]FIG. 16 is an exploded view of a distal portion of yet a furtherembodiment of the apparatus of the present invention.

[0033]FIG. 17 is a cross-sectional and partially exploded view of thedistal portion of FIG. 16, shown treating a portion of a wall of acavity in accordance with the present invention, taken along line 17-17of FIG. 16.

[0034]FIG. 18 is an enlarged perspective view, similar to FIG. 11, of adistal portion of another embodiment of the apparatus of the presentinvention.

[0035]FIG. 19 is an enlarged perspective view, similar to FIG. 18, of adistal portion of a further apparatus of the present invention.

[0036]FIG. 20 is an enlarged cross-sectional view, similar to FIG. 3, ofa distal portion of another embodiment of the apparatus of the presentinvention shown treating a portion of a wall of a cavity in accordancewith the present invention.

[0037]FIG. 21 is an enlarged perspective view, similar to FIG. 11, of adistal portion of a further embodiment of the apparatus of the presentinvention.

[0038]FIG. 22 is a cross-sectional view of the distal portion of FIG. 21taken along line 22-22 of FIG. 21.

[0039]FIG. 23 is a cross-sectional view of a distal portion of yetanother embodiment of the apparatus of the present invention.

[0040]FIG. 24 is a perspective view of a distal portion of yet a furtherembodiment of the apparatus of the present invention.

[0041]FIG. 25 is a perspective view of a distal portion of anotherembodiment of the apparatus of the present invention.

[0042]FIG. 26 is a plan view of a kit, somewhat schematic and partiallycut away, for treating a portion of a wall forming a cavity in a body inaccordance with the present invention.

[0043]FIG. 27 is an exploded side elevational view of the distal portionof a further embodiment of the apparatus of the present invention.

[0044]FIG. 28 is an exploded perspective view of a portion of theapparatus of FIG. 27.

[0045]FIG. 29 is an assembled perspective view of the portion of theapparatus shown in FIG. 28.

DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0046] Reference will now be made in detail to the preferred embodimentsof the invention, examples of which are illustrated in the accompanyingdrawings. While the invention will be described in conjunction with thepreferred embodiments, it will be understood that they are not intendedto limit the invention to those embodiments. On the contrary, theinvention is intended to cover alternatives, modifications andequivalents, which may be included within the spirit and scope of theinvention as defined by the appended claims.

[0047] In general, an apparatus 40 for treating the gastrointestinaltract in a body of a mammal is provided. The apparatus 40 comprises anelongate probe member 41 that can include an overtube member and/orovertip member used in combination with a probe for introducing amaterial into a wall of the gastrointestinal tract to form one or moreimplants in the wall. In one embodiment shown in FIG. 1, a tubularassembly such as an overtube assembly 42 is used in combination with aconventional probe device 44 to form a protrusion in a portion of thewall of the gastrointestinal tract into which an implant-formingsolution is injected. Medical apparatus or medical treatment device 40shown in FIG. 1 includes probe member or probe 44 and overtube assembly42, with the overtube assembly 42 being considered part of the distalextremity of elongate probe member 41. An optical viewing device 48 isincluded in probe 44 and a needle assembly 52 is slidably carried byelongate probe member 41, and in this embodiment by probe 44. Treatmentdevice 40 further includes a supply assembly 58 mounted to the proximalend portion of needle assembly 52. Overtube assembly 42 is removablymounted on the distal extremity of probe 44. In another embodiment, ashortened tubular assembly such as an overtip assembly is used incombination with the probe, instead of an overtube assembly, to form aprotrusion and introduce the solution. In a further embodiment, anovertube member is used in combination with an overtip assembly and aprobe. In each embodiment, a solid is formed in the wall from thematerial to treat the wall. A kit for use in the above procedure isprovided.

[0048] A conventional or other suitable gastroscope or endoscope can beused for probe 44. The exemplary probe 44 shown in FIGS. 1-3 is anOlympus CF Type 40L/I endoscope made by Olympus Corporation of TokyoJapan. Probe 44 includes a flexible elongate tubular member or insertiontube 54 having proximal and distal extremities 54 a and 54 b and adistal face 56. A handle means or assembly is coupled to proximalextremity 54 a of elongate first member or insertion tube 54 andincludes a conventional probe handle 62. The tubular insertion tube 54includes a plurality of bores or passageways extending axially fromproximal extremity 54 a to distal extremity 54 b. A plurality of fivesuch passageways, including a central passageway 64, are shown in FIG.2.

[0049] Referring to FIGS. 1 and 2, optical viewing device 48 is formedintegral with probe 44 and has an optical element or objective lens 66carried by the central passageway 64 of insertion tube 54. Lens 66 has afield of view at distal face 56 which permits the operator to viewforwardly of insertion tube distal extremity 54 b. In particular, lens66 has a field of view that includes the portion of a pressure chamber68 formed within a distal end 72 b of a second member or overtube member72 and the portion of end cap 74 which are located forwardly ofinsertion tube distal extremity. Optical viewing device 48 furtherincludes an eye piece 76 mounted on a proximal end of probe handle 62.Second and third illumination passageways 78, 80 are provided ininsertion tube 54 peripherally of central passageway 64 for carryingrespective light fiber assemblies or light guides 82. A connection cable84, a portion of which is shown in FIG. 1, extends from probe handle 62to a conventional light source 86. First and second light guides 82extend through insertion tube 54 and cable 84 for providing illuminationforwardly of insertion tube 54.

[0050] A working passageway or channel 88 is further provided ininsertion tube 54 and extends to a side port 90 formed in probe handle62. An additional passageway 92 extends through insertion tube 54 andcan be used as an air and/or water inlet or outlet or a lumen forproviding suction. Insertion tube 54 is flexible so as to facilitate itsinsertion and advancement through a body and includes a bendable distalend for selectively directing distal face 56 in a desired direction. Aplurality of finger operable controls 94 are provided on probe handle 62for, among other things, operating the bendable distal end of insertiontube 54 and the supply and removal of fluids through the insertion tube54.

[0051] Referring to FIGS. 1 and 4, needle assembly 52 can be of anyconventional type such as a modified sclerotherapy needle similar to theBard® Flexitip™ needle manufactured by C.R. Bard, Inc. of Billerica, Md.Needle assembly 52 includes a needle member or needle 96 having aproximal end portion 96 a and a distal end portion 96 b. Needle assembly52 may include an optional sleeve member or sleeve 98 having a proximalend portion or extremity 98 a and a distal end portion or extremity 98b. Sleeve or elongate tubular member 98 is made from any suitablematerial such as flexible plastic or metal and has a lumen extendinglongitudinally therethrough for receiving needle 96. The sleeve 98 andthe needle 96 are slidable relative to each other in a longitudinaldirection. In this regard, tubular needle 96 is slidably disposed insleeve 98 and movable from a retracted position in which tubular needle96 is recessed within distal end portion 98 b to an extended position inwhich needle 96 projects distally of sleeve 98. Needle 96 and sleeve 98can be slidably disposed within working channel 88 and side port 90 ofinsertion tube 54 and each have a length so that when distal endportions 96 b and 98 b are extending from distal extremity 54 b ofinsertion tube 54 or otherwise in the vicinity of distal face 56,proximal end portions 96 a and 98 a are accessible at side port 90.Needle 96 is provided with a lumen or internal passage 100 extendinglongitudinally therethrough for carrying liquids or other materialsthrough the needle.

[0052] Hollow or tubular needle 96 has an internal passage 100 extendinglongitudinally therethrough from proximal end portion 96 a to distal endportion 96 b. The modified needle distal end portion 96 b is made fromany suitable material such as stainless steel and has a size rangingfrom 16 to 28 gauge and preferably ranging from 21 to 26 gauge. As shownmost clearly in FIG. 4, the distal end portion 96 b has a cylindricalwall 102 for forming internal passage 100 and also has a sharpened orbeveled distal end 104 formed in part by a tapered end surface 106. Atleast one opening is provided in distal end portion 96 b and can includeor consist of an opening 108 a provided in tapered end surface 106. Asan alternative to or in addition to opening 108 a, at least one and asshown a plurality of openings can be provided in cylindrical wall 102.For example, two openings 108 b and two additional openings 108 c areprovided in wall 102. Openings 108 b are diametrically disposed relativeto each other, so as to be 180° apart, and openings 108 c are alsodiametrically disposed relative to each other but offset 90° fromopenings 108 b. The openings 108 c are spaced longitudinally behind theopenings 108 b. Openings 108 b and 108 c can be any suitable shape orsize and are shown as being elongate or oblong in shape.

[0053] It should be appreciated that a needle distal end portion 96 bhaving only openings 108 b or openings 108 c can be provided and bewithin the scope of the present invention. In one embodiment (notshown), tapered surface 106 may be closed and openings 108 are providedonly in cylindrical wall 102. Needle proximal end portion 96 a and thecentral portion of needle 96 can be made from plastic, metal or anyother suitable material. Other needle configurations may also be used.For example, the needle may be provided with a sharpened or pointeddistal end which is generally conical in shape and has no opening (notshown). Also, three or more circumferentially-disposed openings may beprovided at substantially equal separation angles. For example, in thecase of three circumferentially spaced openings, each may be spaced 120°from the other openings (not shown).

[0054] A fluid connector 110 is secured or coupled to proximal endportion 96 a of needle 96 and a gripping member or grip 112 is securedto the proximal end portion 98 a of sleeve 98, as shown in FIG. 1. Fluidconnector 110 includes first and second Luer fitting portions 114 and116, or any other suitable fitting portions, which communicate withpassage 100 in needle 96. First Luer fitting portion 114 is capped inFIG. 1. Fluid connector 110 and grip 112 are longitudinally movablerelative to each other so as to cause relative longitudinal movementbetween needle 96 and sleeve 98. More specifically, grip 112 can be slidforwardly and rearwardly on proximal end portion 96 a of needle 96relative to fluid connector 110. Movement of grip 112 forwardly relativeto fluid connector 110 causes distal end portion 98 b of sleeve 98 toextend filly over distal end portion 96 b of needle 96 so that theneedle has filly retracted within sleeve 98. Conversely, movement ofgrip 112 rearwardly relative to fluid connector 110 causes sleeve distalend portion 98 b to retract relative to needle distal end portion 96 bso as to expose needle distal end portion 96 b.

[0055] The handle means of treatment device 40 includes supply assembly58 coupled to proximal extremity 54 a of insertion tube 54 (FIG. 1).More specifically, supply assembly 58 is secured to the proximalextremity of needle assembly 52. The supply assembly 58 is includedwithin the means of treatment device 40 for introducing a liquid,solution or other material through passage 100 of needle 96 and out oneor more of the openings 108 provided in needle distal end portion 96 b.Supply assembly 58 may comprise a conventional syringe or first syringe118 having a reservoir or barrel 120 provided with any suitable fittingportion such as Luer fitting portion 122 at the forward end thereof anda plunger 124 for dispelling liquid within barrel 120 through Luerfitting portion 122.

[0056] Any suitable material, from which an implant can be formed whenthe fluid, separately or in conjunction with another fluid, isintroduced into the body, can be provided in syringe 118. Althoughaqueous or non-aqueous solutions are amongst the fluids that can beused, an inert, nonresorbable material is preferred. One such materialcomprises at least one solution which when introduced into the bodyforms a nonbiodegradable solid. As used herein, a solid means anysubstance that does not flow perceptibly under moderate stress, has adefinite capacity for resisting forces which tend to deform it (such ascompression, tension and strain) and under ordinary conditions retains adefinite size and shape; such a solid includes, without limitation,spongy and/or porous substances. One such embodiment of the at least onesolution is first and second solutions which when combined in the bodyform the nonbiodegradable solid. Another such embodiment is a nonaqueoussolution which can be introduced into the body as a liquid and fromwhich a solid thereafter precipitates. A preferred embodiment of such anonaqueous solution is a solution of a biocompatible polymer and abiocompatible solvent which can optionally include a contrast agent forfacilitating visualization of the solution in the body.

[0057] A particularly preferred implant-forming or bulking solution is acomposition comprising from about 2.5 to about 8.0 weight percent of abiocompatible polymer, from about 52 to about 87.5 weight percent of abiocompatible solvent and optionally from about 10 to about 40 weightpercent of a biocompatible contrast agent having a preferred averageparticle size of about 10 μm or less. It should be appreciated that anypercentages stated herein which include a contrast agent would beproportionally adjusted when the contrast agent is not utilized. Anycontrast agent is preferably a water insoluble biocompatible contrastagent. The weight percent of the polymer, contrast agent andbiocompatible solvent is based on the total weight of the completecomposition. In a preferred embodiment, the water insoluble,biocompatible contrast agent is selected from the group consisting ofbarium sulfate, tantalum powder and tantalum oxide. In still a furtherpreferred embodiment, the biocompatible solvent is dimethylsulfoxide(DMSO), ethanol, ethyl lactate or acetone.

[0058] The term “biocompatible polymer” refers to polymers which, in theamounts employed, are non-toxic, chemically inert, and substantiallynon-immunogenic when used internally in the patient and which aresubstantially insoluble in physiologic liquids. Suitable biocompatiblepolymers include, by way of example, cellulose acetates (includingcellulose diacetate), ethylene vinyl alcohol copolymers, hydrogels(e.g., acrylics), poly(C₁-C₆) acrylates, acrylate copolymers, polyalkylalkacrylates wherein the alkyl and alk groups independently contain oneto six carbon atoms, polyacrylonitrile, polyvinylacetate, celluloseacetate butyrate, nitrocellulose, copolymers of urethane/carbonate,copolymers of styrene/maleic acid, and mixtures thereof. Copolymers ofurethane/carbonate include polycarbonates that are diol terminated whichare then reacted with a diisocyanate such as methylene bisphenyldiisocyanate to provide for the urethane/carbonate copolymers. Likewise,copolymers of styrene/maleic acid refer to copolymers having a ratio ofstyrene to maleic acid of from about 7:3 to about 3:7. Preferably, thebiocompatible polymer is also non-inflammatory when employed in situ.The particular biocompatible polymer employed is not critical and isselected relative to the viscosity of the resulting polymer solution,the solubility of the biocompatible polymer in the biocompatiblesolvent, and the like. Such factors are well within the skill of theart.

[0059] The polymers of polyacrylonitrile, polyvinylacetate, poly(C₁-C₆)acrylates, acrylate copolymers, polyalkyl alkacrylates wherein the alkyland alk groups independently contain one to six carbon atoms, celluloseacetate butyrate, nitrocellulose, copolymers of urethane/carbonate,copolymers of styrene/maleic acid and mixtures thereof typically willhave a molecular weight of at least about 50,000 and more preferablyfrom about 75,000 to about 300,000.

[0060] Preferred biocompatible polymers include cellulose diacetate andethylene vinyl alcohol copolymer. In one embodiment, the cellulosediacetate has an acetyl content of from about 31 to about 40 weightpercent. Cellulose diacetate polymers are either commercially availableor can be prepared by art recognized procedures. In a preferredembodiment, the number average molecular weight, as determined by gelpermeation chromatography, of the cellulose diacetate composition isfrom about 25,000 to about 100,000 more preferably from about 50,000 toabout 75,000 and still more preferably from about 58,000 to 64,000. Theweight average molecular weight of the cellulose diacetate composition,as determined by gel permeation chromatography, is preferably from about50,000 to 200,000 and more preferably from about 100,000 to about180,000. As is apparent to one skilled in the art, with all otherfactors being equal, cellulose diacetate polymers having a lowermolecular weight will impart a lower viscosity to the composition ascompared to higher molecular weight polymers. Accordingly, adjustment ofthe viscosity of the composition can be readily achieved by mereadjustment of the molecular weight of the polymer composition.

[0061] Ethylene vinyl alcohol copolymers comprise residues of bothethylene and vinyl alcohol monomers. Small amounts (e.g., less than 5mole percent) of additional monomers can be included in the polymerstructure or grafted thereon provided such additional monomers do notalter the implanting properties of the composition. Such additionalmonomers include, by way of example only, maleic anhydride, styrene,propylene, acrylic acid, vinyl acetate and the like.

[0062] Ethylene vinyl alcohol copolymers are either commerciallyavailable or can be prepared by art recognized procedures. Preferably,the ethylene vinyl alcohol copolymer composition is selected such that asolution of 8 weight-volume percent of the ethylene vinyl alcoholcopolymer in DMSO has a viscosity equal to or less than 60 centipoise at20° C. and more preferably 40 centipoise or less at 20° C. As isapparent to one skilled in the art, with all other factors being equal,copolymers having a lower molecular weight will impart a lower viscosityto the composition as compared to higher molecular weight copolymers.Accordingly, adjustment of the viscosity of the composition as necessaryfor catheter delivery can be readily achieved by mere adjustment of themolecular weight of the copolymer composition.

[0063] As is also apparent, the ratio of ethylene to vinyl alcohol inthe copolymer affects the overall hydrophobicity/hydrophilicity of thecomposition which, in turn, affects the relative watersolubility/insolubility of the composition as well as the rate ofprecipitation of the copolymer in an aqueous solution. In a particularlypreferred embodiment, the copolymers employed herein comprise a molepercent of ethylene of from about 25 to about 60 and a mole percent ofvinyl alcohol of from about 40 to about 75, more preferably a molepercent of ethylene of from about 40 to about 60 and a mole percent ofvinyl alcohol of from about 40 to about 60.

[0064] The term “contrast agent” refers to a biocompatible (non-toxic)radiopaque material capable of being monitored during injection into amammalian subject by, for example, radiography. The contrast agent canbe either water soluble or water insoluble. Examples of water solublecontrast agents include metrizamide, iopamidol, iothalamate sodium,iodomide sodium, and meglumine. The term “water insoluble contrastagent” refers to contrast agents which are insoluble in water (i.e., hasa water solubility of less than 0.01 milligrams per milliliter at 20°C.) and include tantalum, tantalum oxide and barium sulfate, each ofwhich is commercially available in the proper form for in vivo use andpreferably having a particle size of 10 μm or less. Other waterinsoluble contrast agents include gold, tungsten and platinum powders.Methods for preparing such water insoluble biocompatible contrast agentshaving an average particle size of about 10 μm or less are describedbelow. Preferably, the contrast agent is water insoluble (i.e., has awater solubility of less than 0.01 mg/ml at 20° C.)

[0065] The term “biocompatible solvent” refers to an organic materialliquid at least at body temperature of the mammal in which thebiocompatible polymer is soluble and, in the amounts used, issubstantially non-toxic. Suitable biocompatible solvents include, by wayof example, dimethylsulfoxide, analogues/homologues ofdimethylsulfoxide, ethanol, ethyl lactate, acetone, and the like.Aqueous mixtures with the biocompatible solvent can also be employedprovided that the amount of water employed is sufficiently small thatthe dissolved polymer precipitates upon injection into a human body.Preferably, the biocompatible solvent is ethyl lactate ordimethylsulfoxide.

[0066] The term “encapsulation” as used relative to the contrast agentbeing encapsulated in the precipitate is not meant to infer any physicalentrapment of the contrast agent within the precipitate much as acapsule encapsulates a medicament. Rather, this term is used to meanthat an integral coherent precipitate forms which does not separate intoindividual components, for example into a copolymer component and acontrast agent component.

[0067] The compositions employed in the methods of this invention areprepared by conventional methods whereby each of the components is addedand the resulting composition mixed together until the overallcomposition is substantially homogeneous. For example, sufficientamounts of the selected polymer are added to the biocompatible solventto achieve the effective concentration for the complete composition.Preferably, the composition will comprise from about 2.5 to about 8.0weight percent of the polymer based on the total weight of thecomposition and more preferably from about 4 to about 5.2 weightpercent. If necessary, gentle heating and stirring can be used to effectdissolution of the polymer into the biocompatible solvent, e.g., 12hours at 50° C.

[0068] Sufficient amounts of the contrast agent are then optionallyadded to the biocompatible solvent to achieve the effectiveconcentration for the complete composition. Preferably, the compositionwill comprise from about 10 to about 40 weight percent of the contrastagent and more preferably from about 20 to about 40 weight percent andeven more preferably about 30 to about 35 weight percent. When thecontrast agent is not soluble in the biocompatible solvent, stirring isemployed to effect homogeneity of the resulting suspension. In order toenhance formation of the suspension, the particle size of the contrastagent is preferably maintained at about 10 μm or less and morepreferably at from about 1 to about 5 μm (e.g., an average size of about2 μm). In one preferred embodiment, the appropriate particle size of thecontrast agent is prepared, for example, by fractionation. In such anembodiment, a water insoluble contrast agent such as tantalum having anaverage particle size of less than about 20 microns is added to anorganic liquid such as ethanol (absolute) preferably in a cleanenvironment. Agitation of the resulting suspension followed by settlingfor approximately 40 seconds permits the larger particles to settlefaster. Removal of the upper portion of the organic liquid followed byseparation of the liquid from the particles results in a reduction ofthe particle size which is confirmed under an optical microscope. Theprocess is optionally repeated until a desired average particle size isreached.

[0069] The particular order of addition of components to thebiocompatible solvent is not critical and stirring of the resultingsuspension is conducted as necessary to achieve homogeneity of thecomposition. Preferably, mixing/stirring of the composition is conductedunder an anhydrous atmosphere at ambient pressure. The resultingcomposition is heat sterilized and then stored preferably in sealedamber bottles or vials until needed.

[0070] Each of the polymers recited herein is commercially available butcan also be prepared by methods well known in the art. For example,polymers are typically prepared by conventional techniques such asradical, thermal, UV, gamma irradiation, or electron beam inducedpolymerization employing, as necessary, a polymerization catalyst orpolymerization initiator to provide for the polymer composition. Thespecific manner of polymerization is not critical and the polymerizationtechniques employed do not form a part of this invention. In order tomaintain solubility in the biocompatible solvent, the polymers describedherein are preferably not cross-linked.

[0071] In another particularly preferred embodiment of theimplant-forming or augmenting solution, the biocompatible polymercomposition can be replaced with a biocompatible prepolymer compositioncontaining a biocompatible prepolymer. In this embodiment, thecomposition comprises a biocompatible prepolymer, an optionalbiocompatible water insoluble contrast agent preferably having anaverage particle size of about 10 μm or less and, optionally, abiocompatible solvent.

[0072] The term “biocompatible prepolymer” refers to materials whichpolymerize in situ to form a polymer and which, in the amounts employed,are non-toxic, chemically inert, and substantially non-immunogenic whenused internally in the patient and which are substantially insoluble inphysiologic liquids. Such a composition is introduced into the body as amixture of reactive chemicals and thereafter forms a biocompatiblepolymer within the body. Suitable biocompatible prepolymers include, byway of example, cyanoacrylates, hydroxyethyl methacrylate, siliconprepolymers, and the like. The prepolymer can either be a monomer or areactive oligomer. Preferably, the biocompatible prepolymer is alsonon-inflammatory when employed in situ.

[0073] Prepolymer compositions can be prepared by adding sufficientamounts of the optional contrast agent to the solution (e.g., liquidprepolymer) to achieve the effective concentration for the completepolymer composition. Preferably, the prepolymer composition willcomprise from about 10 to about 40 weight percent of the contrast agentand more preferably from about 20 to about 40 weight percent and evenmore preferably about 30 weight percent. When the contrast agent is notsoluble in the biocompatible prepolymer composition, stirring isemployed to effect homogeneity of the resulting suspension. In order toenhance formation of the suspension, the particle size of the contrastagent is preferably maintained at about 10 μm or less and morepreferably at from about 1 to about 5 μm (e.g., an average size of about2 μm).

[0074] When the prepolymer is liquid (as in the case of polyurethanes),the use of a biocompatible solvent is not absolutely necessary but maybe preferred to provide for an appropriate viscosity in theimplant-forming solution. Preferably, when employed, the biocompatiblesolvent will comprise from about 10 to about 50 weight percent of thebiocompatible prepolymer composition based on the total weight of theprepolymer composition. When a biocompatible solvent is employed, theprepolymeric composition typically comprises from about 90 to about 50weight percent of the prepolymer based on the total weight of thecomposition.

[0075] In a particularly preferred embodiment, the prepolymer iscyanoacrylate which is preferably employed in the absence of abiocompatible solvent. When so employed, the cyanoacrylate adhesive isselected to have a viscosity of from about 5 to about 20 centipoise at20° C.

[0076] The particular order of addition of components is not criticaland stirring of the resulting suspension is conducted as necessary toachieve homogeneity of the composition. Preferably, mixing/stirring ofthe composition is conducted under an anhydrous atmosphere at ambientpressure. The resulting composition is sterilized and then storedpreferably in sealed amber bottles or vials until needed.

[0077] Several specific embodiments of implant-forming solutionssuitable for use with the apparatus of the present invention aredescribed in U.S. Pat. No. 5,667,767 dated Sep. 16, 1997, U.S. Pat. No.5,580,568 dated Dec. 3, 1996, and U.S. Pat. No. 5,695,480 dated Dec. 9,1997 and International Publication Number WO 97/45131 having anInternational Publication Date of Dec. 4, 1997, the entire content ofwhich is incorporated herein by this reference.

[0078] Supply assembly 58 further includes second and third reservoirsin the form of second and third syringes 126 and 128. Second syringe 126is filled with dimethyl sulfoxide (DMSO) or any other suitable liquid.Third syringe 128 is filled with a saline solution or any other suitableaqueous or physiologic solution.

[0079] A manifold assembly or manifold 130 is provided for couplingsyringes 118, 126 and 128 to fluid connector 110. In one embodiment, themanifold 130 has a plurality of three stopcocks 132, 134, 136 and aplurality of at least two and as shown a plurality of four ports or Luerfitting portions. A first Luer fitting portion 138 cooperatively mateswith forward Luer fitting portion 122 of syringe 118. A second Luerfitting portion 140 cooperatively mates with second Luer fitting portion84 of fluid connector 110. Third and fourth Luer fitting portions 142and 144 are additionally provided. Third Luer fitting portion 142 isconnected by a tube 146, a portion of which is shown in FIG. 1, tosecond syringe 126 and fourth Luer fitting portion 108 is connected by atube 148, a portion of which is shown in FIG. 1, to third syringe 128.Stopcocks 132, 134, 136 operate in a conventional manner to direct fluidflow between Luer fitting portions 138, 140, 142 and 144. In a furtherembodiment of the invention (not shown), syringe 118 can be secureddirectly to fluid connector 110 or proximal end portion 96 a of needle96. It should be appreciated that manifold 130 can alternatively beprovided with any number of Luer fitting portions or be of any otherconfiguration for coordinating fluid flow from a plurality of syringesor other fluid reservoirs.

[0080] Supply assembly 58 further includes a delivery device or gun 150for supplying a plurality of discrete preselected amounts of the fluidwithin barrel 120 to needle 96 (see FIGS. 1 and 5). Gun 150 has acylindrical housing 152 made from plastic or any other suitable materialfor receiving syringe barrel 120. Housing 152 is formed from a baseportion 154 and a cover portion 156 pivotally secured to base portion154 by hinge 158. A latch 160 is pivotally coupled to cover portion 156for engaging base portion 154 and thereby locking cover portion 156 in aclosed position. Housing 152 has a forward opening 162 for receivingLuer fitting portion 122 of syringe 118. A handle 164 made from plasticor any other suitable material depends from base portion 154. Handle 164has an internal cavity 166. First and second spaced-apart reinforcingmembers 168 and 170 extend downwardly from base portion 154 at the frontand rear of handle 164. Reinforcing members 168 and 170 arelongitudinally aligned and are each provided with a bore 172 extendinglongitudinally therethrough and opening into internal cavity 166. A rod174 made from plastic or any other suitable material is slidablydisposed within bores 172. Rod 174 has a paddle 176 extending upwardlyfrom the rear thereof perpendicularly to the longitudinal axis of therod. Paddle 176 is adapted to engage the end of syringe plunger 124. Aring 178 sized for receiving a finger of a human hand extends rearwardlyfrom paddle 176 for facilitating the pulling of rod 174 rearwardly inbores 172.

[0081] Rod 174 and paddle 176 are included within the finger operablemeans of gun 150 for causing incremental relative movement betweenbarrel 120 and plunger 124 of syringe 118. A trigger 180 extends from anopening 182 at the front of handle 164 below rod 174. The trigger isslidably disposed in a direction parallel to the longitudinal axis ofrod 174 between first and second spaced-apart guides 184 provided ininternal cavity 166. Trigger 180 moves between a first or fully extendedposition to a second or fully retracted position. A lever 186 ispivotally coupled to handle 164 by means of a pin 188. The lever 186 hasa first end portion 186 a which extends behind trigger 180 and a secondend portion 186 b having a wedge-like shape for engaging one of aplurality of longitudinally spaced-apart notches formed in the bottom ofrod 174. When trigger 180 is pulled rearwardly by the finger of a humanhand, the trigger engages lever first end portion 186 a to cause lever186 to pivot about pin 188 from a first or home position to a second oroperational position. Lever second end portion 186 b moves forwardlyduring this half-stroke to engage one of notches 190 and cause rod 174to move forwardly relative to housing 152. Paddle 176 follows rod 174and incrementally pushes plunger 124 into barrel 120 for each pull oftrigger 180.

[0082] A fixed stop 192 is provided in handle 164 for limiting therearward movement of trigger 180 and thus determining the incrementalamount of fluid within barrel 120 dispelled from syringe 118 with eachpull of trigger 180. The rearward travel of trigger 180 can beselectively limited by means of one or more additional pins or stops194, one of which is shown in FIG. 5. Adjustable limit pin 194 isslidably mounted within handle 164 for movement from a first positionout of the path of trigger 180 to a second position within the path oftrigger 180 so as to selectively limit the rearward stroke of trigger180 when engaged and placed in its second position.

[0083] A coil spring or any other suitable biasing number is providedhaving one end coupled to a pin mounted within handle 164 and a secondend secured to second end portion 186 b of lever 186. The coil springurges lever 186 back to its home position, out of engagement withnotches 190, when the finger pressure on trigger 180 is released. Thecoil spring causes lever first end portion 186 a to push trigger 180outwardly from opening 182 to its home position.

[0084] A finger operable adjustment mechanism 196 is connected to needleproximal end portion 96 a and sleeve proximal end portion 98 a forcausing longitudinal relative movement between the needle 96 and sleeve98. The adjustment mechanism 196 can be of any suitable type for usewith any suitable needle assembly having a needle and sleeve which areadjustable relative to each other. One embodiment of such an adjustmentmechanism 196 is carried by gun 150. As shown in FIG. 1, such adjustmentmechanism 196 has a first or forward post 198 and a second or rear post200 extending upwardly from the top of cover portion 156. Thelongitudinally spaced-apart posts 198 and 200 extend perpendicularly tobarrel 120. A slidable member or slide bar 202 is slidably mounted in abore (not shown) provided in forward post 198 for forward and rearwardmovement in a direction parallel to barrel 120. A thumb screw 204 havingan enlarged head 204 a is slidably disposed in a bore (not shown)provided in rear post 200. Screw head 204 a abuts rear post 200 and theother end of screw 204 is threadably received within the back end ofslide bar 202. Counterclockwise rotation of thumb screw 204 relative torear post 200 causes slide bar 202 to move rearwardly toward forwardpost 198, while clockwise rotation of thumb screw 204 results in slidebar 202 moving forwardly away from post 198. An L-shaped coupler 206 ispivotally coupled to the forward end of slide bar 202 by means of a pin208. Coupler 206 has first and second spaced-apart arms 210 forming aslot 212 therebetween for receiving the central portion of grip 112. Ascrew 214 extends between arms 210 for locking the arms to grip 112 andthus longitudinally locking sleeve 98 relative to needle 96.

[0085] Overtube assembly 42 of the present invention includes anelongate tubular member or overtube member 72 (see FIGS. 1-3). Overtubemember 72 may be formed of either rigid or flexible materials. Forexample, overtube member 72 may be formed of rigid plastic tubing,flexible plastic tubing or flexible silicon tubing and can be made fromany suitable material such as polyetheretherketone (PEEK), polypropylene(PP) or fluorinated ethylene propylene (FEP). Preferably, overtubemember 72 is optically clear and is flexible such that it provides atight frictional seal against insertion tube 54 at its proximal portionand/or at its distal portion end cap 74. Overtube member 72 includes aproximal end portion 72 a and a distal end portion 72 b. Overtubeassembly 42 has a length preferably approximate the length of insertiontube 54, as for example a length ranging from 100 to 150 centimeters andpreferably approximately 125 centimeters, and a diameter ranging from0.5 to 2.5 centimeters and preferably ranging from 0.75 to 1.5centimeters. One should appreciate, however, the length of overtubeassembly 42 may vary depending upon the size of probe 44, the intendedpatient and other factors.

[0086] The overtube assembly 42 is rotatably mounted on at least aportion of insertion tube 54. A seal 216 having a seal aperture 218 isprovided on overtube member 72 and is shown as being provided on theproximal end of the overtube member 72. Insertion tube 54 may beinserted into overtube assembly 42 through seal aperture 218 therebyforming an internal chamber or pressure chamber 68 between insertiontube 54 and overtube assembly 42. A suction source 220 is coupled withovertube assembly 42 via a suction source coupling 222 to producenegative pressure within pressure chamber 68. Suction source 220 mayinclude any well known suction devices such as a suction pump or aconventional 50 cubic centimeter syringe.

[0087] Overtube assembly 42 includes an end cap 74 secured to distal endportion 72 b of overtube member 72 by any suitable means such as heatsealing, adhesive, threads or press fit. End cap 74 has a length rangingfrom one to ten centimeters and preferably ranging from two to threecentimeters and may be formed by injection molding or machining from anysuitable material. The end cap 74 is preferably made from a clearplastic such as polymethylpentene (PMP) or acrylic. The end cap 74 hasan outer surface preferably in the form of outer cylindrical surface 224and an outer diameter approximately equal to the outer diameter ofovertube member 72. End cap 74 includes a rounded end or blunt nose 225which facilitates insertion into and advancement through thegastrointestinal tract thus preventing or minimizing injury to thereto.End cap 74 is provided with a central passageway or bore 223 thatcommunicates with chamber 68 and terminates at an opening formed inblunt nose 225. An optical window 226 made from any suitable material issecured to nose 225 at the opening to enable optical viewing device 48to provide visual feedback of the gastrointestinal tract beyond end cap74.

[0088] End cap 74 is formed with at least one recess or vacuum cavity227 that opens onto outer surface 224. One should appreciate that one,two, three, four or more recesses or vacuum cavities 227 may be providedin the distal extremity of overtube assembly 42. Such vacuum cavitiescan be circumferentially disposed about the end cap, as shown in FIG. 1where three of four circumferentially spaced-apart cavities 227 areshown and as shown in FIG. 7 where four circumferentially spaced-apartcavities 227 are shown. Each of the vacuum cavities 227 of end cap 74 iselongated and is formed in part by a flat cavity base 229. A peripheralwall 231 serves as the side wall of the vacuum cavity 227. One shouldappreciate that the size and shape of vacuum cavity may vary inaccordance with the medical procedure with which it is used. Forexample, vacuum cavity may have a semispherical shape. Each vacuumcavity 227 is fluidly connected to pressure chamber 68 by means of atleast one passageway 232 which extends from the cavity 227 to centralbore 223. Vacuum openings or apertures 228 are located in a portion ofend cap 14 which forms a cavity base 229 of each vacuum cavity 227, asshown in FIG. 3, and serve as the openings for respective internalpassageways 232 into the vacuum cavity. Each recessed wall or base 229is provided with a plurality of apertures 228 therein and, morespecifically, has a plurality of six apertures arranged in two rows withthree apertures in each row. Although base 229 is shown as being planar,it should be appreciated that the base 229 can be nonplanar, such asconcave or convex, and be within the scope of the present invention.

[0089] Insertion tube 54 extends through overtube member 72 such thatdistal extremity 54 b is adjacent to distal end 72 b (see FIGS. 1 and3). Optical viewing device 48 provides visual feedback about needles 96when they are extended from distal face 56 of insertion tube 54 intovacuum cavity 227. Overtube assembly 42 may include four vacuum cavities227 and four corresponding needle guides 234. An identifying referencemark 236 such as a spline may be provided on the inside of overtubemember 72 adjacent distal end 72 b that is viewable through probe 44 todefine a reference point for determining the position of needle 96 withrespect to the four vacuum cavities 227. Any other suitable identifyingreference mark 236, such as an etched and inked mark on the inside ofthe overtube member 72, can alternatively be provided. Use of theidentifying mark 236 provides a relative position, for example a twelveo'clock position, of probe 44 within overtube assembly 42.

[0090] Treatment device 40 can be used for any suitable procedure withinthe upper gastrointestinal tract, such as the treatment ofgastroesophageal reflux disease (GERD). A portion of a human body 238 isshown in FIGS. 6 and 7 and has an internal cavity in the form ofesophagus 240 extending through a lower esophageal sphincter 242 to astomach 244. Such cavity is accessible by a natural body opening in theform of a mouth (not shown) and is defined by an intraluminal wall 232.Esophagus 240 is part of the gastrointestinal tract of body 238 thatextends from the mouth to an anus (not shown). An esophageal mucosa 246serves as the inner layer of intraluminal wall 232 in the esophagus 240and gastric mucosa 248 serves as the inner layer of the intramural wall232 in stomach 244. The esophageal mucosa and the gastric mucosa meet ata squamocolumnar junction 250. Wall 232 has a muscle layer comprisinglayer of circular muscle 252 extending beneath mucosa layers 246 and 248and layer of longitudinal muscle 254 beneath circular muscle 252. Themuscle layers 252 and 254 each extend around esophagus 240 and stomach244. Wall 232 further includes a submucosal layer or submucosa 256extending between the mucosa and the muscle layers. A submucosal space,that is a potential space, can be created between mucosa layer 246 or248 and circular muscle layer 252 by the separation of layer 246 or 248from muscle layer 252. In addition, as with any muscle, wall 232includes an intramuscular potential space, that is a space which can becreated intramuscularly by distension and separation of muscle fiberswithin a single muscle or between layers of muscle. Wall 232 has a depthor thickness which includes at least mucosa layers 246 and 248, musclelayers 252 and 254 and submucosa 256. A phreno-esophageal ligament 258and a diaphragm 260 extend around esophagus 240 above lower esophagealsphincter 242.

[0091] In one method of the present invention, at least oneimplant-forming solution is introduced into the wall 232 of thegastrointestinal tract to form at least one implant 264 in the wall 232of the gastrointestinal tract. In one preferred method of operation anduse, the apparatus of the present invention is used to inject theimplant-forming solution into a portion of a wall forming a cavity in abody in a procedure similar to that disclosed in U.S. patent applicationSer. No. 09/286,245 filed Apr. 15, 1999, the entire content of which isincorporated herein by this reference. In particular, overtube assembly42 and treatment device 40 are used in accordance with the presentinvention to form a protrusion 230 in a portion of wall 232 into whichan implant-forming solution is injected.

[0092] In one embodiment, syringe 118 is filled with the implant-formingsolution in preparation of the procedure. Syringe 118 is loaded into gun150 by opening cover portion 156 to permit placement of barrel 120within housing 152. Ring 178 is grasped to pull rod 174 rearwardlyrelative to housing 152 so that paddle 176 is disposed behind theretracted plunger 124. Cover portion 156 is closed and secured to baseportion 154 by means of latch 160. The physician thereafter pullstrigger 180 as necessary to cause paddle 176 to engage the rear ofplunger 124.

[0093] Supply assembly 58 is attached to needle assembly 52 after needle96 and sleeve 98 have been disposed in working channel 88 of probe 44.Alternatively, supply assembly 52 can be attached to the needle assemblyprior to such disposition of the needle assembly within probe 44. Ineither case, attachment is accomplished by coupling first Luer fittingportion 138 of manifold 130 to Luer fitting portion 122 of syringe 118and second Luer fitting portion 106 of the manifold to first Luerfitting portion 156 of fluid connector 110. Coupler 206 is pivoteddownwardly so that first and second arms 176 thereof engage grip 112 andscrew 179 tightened to secure grip 112 in slot 178 between arms 176.Thumb screw 204 is rotated in a counterclockwise direction relative torear post 186 to ensure that needle 96 is fully retracted within sleeve98. Thereafter, saline solution syringe 128 is coupled by means of tube148 to third Luer fitting portion 142 of manifold 130 and DMSO syringe126 is coupled by means of tube 146 to fourth Luer fitting portion 144of the manifold.

[0094] Probe 44 is prepared by connecting light cable 84 to light source86 and attaching the proper eyepiece 76 to probe handle 62. In addition,all other conventional attachments are applied to probe 44. Insertiontube 54 is then inserted within overtube assembly 42 via aperture 218 ofseal 216.

[0095] After the patient has been appropriately sedated or anesthetized,probe handle 62 is grasped by the physician to introduce distal end 72 bof overtube assembly 42 and distal extremity 54 b of probe 44 into themouth of the patient and to advance overtube assembly 42 with insertiontube 54 down esophagus 240. Optical viewing device 48 facilitatesadvancement by the physician of the insertion tube 54 and the overtubeassembly 42. In addition, the optical viewing device 48 enables thephysician to ensure that overtube assembly 42 is properly disposedwithin esophagus 240. Insertion tube 54 and overtube assembly 42 eachhave a length so that when distal extremity 54 b and distal end 72 b arein the vicinity of lower esophageal sphincter 242, proximal extremity 54a and proximal end 72 a are outside of body 238. The optically clearmaterial of end cap 74 permits light from light guides 82 to illuminatethe esophagus and thus enhance visualization by optical viewing device48 through window 226.

[0096] Although the method of positioning overtube assembly 42 withinthe esophagus is described herein as utilizing an optical viewingdevice, it should be appreciated that the overtube assembly can beintroduced into the esophagus without the aid of an optical viewingdevice. For example, the overtube assembly 42 can be positioned in theesophagus by merely introducing the distal end of the overtube assemblya predetermined distance to the desired treatment site. The insertiondistance of overtube assembly 42 can be measured by external observationof the proximal extremity of assembly and optionally by gradations (notshown) provided on the outer surface of such proximal extremity.

[0097] A portion of the procedure for treating wall 232 in the vicinityof lower esophageal sphincter 242 is shown in FIG. 6. Under the guidanceof optical viewing device 48, which has a field of view forward distalface 56 of insertion tube 54 and forward of overtube assembly 42 throughoptical window 226, overtube assembly 42 is maneuvered to a positionsuch that at least one vacuum cavity 227 is adjacent the portion of wall232 which is to be treated. Suction source 220 is then activated to drawair from and evacuate pressure chamber 68 of overtube assembly 42. Anegative pressure is thus created within the pressure chamber 68 and thevacuum cavities 227. This negative pressure creates a suction effectwhich draws targeted tissue, that is a portion of wall 232 to betreated, into vacuum cavity 227 to form a protrusion 230 in the targetedtissue, as shown in FIG. 6. It should be appreciated that FIGS. 6 and 7are somewhat schematic and that, in this regard, the size of esophagus240 has been exaggerated relative to the size of insertion tube 54 andovertube 72 in FIG. 6. The sizing of esophagus 240 relative to insertiontube 54 and overtube 72 are more accurate in FIG. 7.

[0098] Distal end portions 96 b and 98 b of needle assembly 52 are nowadvanced until such distal end portions of needle 96 and sleeve 98 arein the vicinity of insertion tube distal extremity 54 b, overtube distalend 72 b and end cap 74. Needle 96 and sleeve 98 are each movable from afirst position in which distal end portions 96 b and 98 b are eachretracted within insertion tube 54 and thus recessed within workingchannel 88 to a second position in which the distal end portions 96 band 98 b extend distally beyond the end of insertion tube 54. The needleand sleeve each have a sufficient length so that the physician holdinggun 150 can extend both the needle and the sleeve distally from distalextremity 54 b. The physician retracts sleeve 98 relative to needle 96by means of adjustment mechanism 196 so that needle distal end portion96 b extends beyond sleeve distal end portion 98 b a selected amount ofat least two millimeters and preferably ranging from two to 15millimeters. Such amount of extension can be easily determined forexample by correlating such extension as a function of the rotation ofthumb screw 204 and properly calibrating the position of thumb screw 204relative to rear post 200 in this regard.

[0099] The physician primes needle 96 with the saline or other aqueousor physiologic solution from syringe 128 and ensures that needle passage100 is filled with saline solution by observing with optical viewingdevice 48 the saline solution being dispelled from the one or moreopenings 108 in needle distal end portion 96 b. For simplicity, theoperation of conventional stopcocks 132, 134, 136 for directingappropriate fluids to and from needle passage 100 will not be discussedin connection with the procedure.

[0100] The physician advances sleeve 98 and needle 96 distally frominsertion tube distal extremity 54 b into a respective needle guide 234such that sleeve 98 and needle 96 are proximate to the protrusion 230.The physician extends needle 96 through needle guide 234 into vacuumcavity 227, which is occupied by the portion of wall 232 to be treated,by moving the needle 96 and sleeve 98 closer to side port 90. Thiscauses sharpened end 104 of needle 96 to penetrate protrusion 230 ofwall 232. The field of view of optical viewing device 48 permits thephysician to observe movement of needle 96 into needle opening or guide234 and, in some cases, penetration of protrusion 230. The opticallyclear material of end cap 74 permits light guides 82 to enhance suchvisualization. It is noted that the amount of extension of needle 96into vacuum cavity 227 can be determined for example by correlating suchextension as a function of the rotation of thumb screw 204 and properlycalibrating the position of thumb screw 204 in relation to rear post200, as discussed above.

[0101] Saline solution may be injected into wall 232 to cause esophagealmucosa 246 or gastric mucosa 248, as the case may be, to separate fromcircular muscle 252 and further enlarge protrusion 230 in wall 232providing an internal space 262 filled with the saline solution. Theamount of saline solution required to create space 262 can range from0.25 to ten cubic centimeters and preferably range from one to threecubic centimeters. The physician then retracts needle 96 from space 262,cavity 227 and guide 234 and withdraws the remaining saline solutionfrom passage 100 by means of pulling back the plunger on syringe 128 orby any other suitable method. The physician next cleanses needle passage100 with DMSO from syringe 126 to ensure that the saline solution hasbeen removed from passage 100. DMSO cleansing can be determined byobserving a slight amount of DMSO being dispelled from needle distal endportion 96 b. This cleansing step is enhanced by the introduction of theDMSO downstream of saline stopcock 103 and upstream of implant-formingsolution stopcock 101. The DMSO is now removed from passage 100 bywithdrawing the plunger of syringe 126 or by any other suitable means.Removal of the saline solution from passage 100 and the cleansing of thepassage with DMSO inhibits premature precipitation within syringe 118 ofthe biocompatible polymer in the implant-forming solution from the DMSOin the implant-forming solution. Needle passage 100 is next primed withthe implant-forming solution carried by syringe 118 until such solutionis available at the openings 108 in needle distal end portion 96 b.

[0102] The physician again positions insertion tube distal extremity 54b within overtube assembly 42 such that needle 96 aligns with needleguide 234 and causes needle distal end portion 96 b to extend throughneedle guide 234 and penetrate protrusion 230 and extend into space 262.Thereafter, the physician pulls trigger 180 to cause the desiredpreselected amount of implant-forming solution to be introduced throughneedle 96 extending through probe 44 into space 262. The openings 108 inneedle distal end portion 96 b are positioned so that theimplant-forming solution is preferably introduced into the middle ofspace 262. The contrast agent within the implant-forming solutionpermits the viewing of the implant-forming solution by means offluoroscopy. In addition, the introduction of the implant-formingsolution into wall 232 can be monitored transabdominally ortransesophageally by ultrasound. The rate of injection of theimplant-forming solution into space 262 can range from 0.1 cubiccentimeters per minute to ten cubic centimeters per minute.

[0103] Once the implant-forming solution has been introduced into wall232, the biocompatible polymer of the implant-forming solutionprecipitates to form one or more discrete deposits or solid implants 264(see FIG. 6). The amount or bolus of implant-forming solution injectedinto wall 232 for each implant can range from 0.05 cubic centimeters to10 cubic centimeters. The ratio of implant-forming solution to saline inspace 262 can range from 2:1 to 1:8 and preferably range fromapproximately one part implant-forming solution to two to three partssaline solution. In one embodiment, space 262 created by the salinesolution predefines the configuration of the precipitant or implant 264.As can be seen from FIG. 6, the discrete implant 264 shown thereinoccupies less than all of space 262. In another embodiment (not shown),more implant-forming solution than saline is introduced into wall 232 sothat the discrete implant 264 more than fills the space 262 created bythe saline.

[0104] An injection of a suitable aqueous or physiologic solution suchas a saline solution into wall 232 prior to the injection of theimplant-forming solution creates a space 262 which pushes wall 232against vacuum cavity 227. The injection of the implant-forming solutioninto the saline filled space 262 facilitates rapid precipitation andenhanced solidification of the biocompatible polymer. This rapidsolidification facilitates the desired shaping of implant 264, which isshown in FIG. 6 as being somewhat spherical and elongated in shape andas substantially corresponding to the shape of vacuum cavity 227. It hasalso been found that the saline solution facilitates the creation of arelatively soft and spongy implant 264. After completion of theinjection of implant-forming solution and the solidification of thebiocompatible polymer, the remaining solution within space 262 disperseswithin body 238 and the space 262 contracts about implant 264 (see FIG.7).

[0105] Although only a single implant 264 in wall 232 in the vicinity ofthe lower esophageal sphincter 242 is shown in FIGS. 6 and 7, additionalimplants may be created in wall 232. In preparation thereof, needle 96is removed from protrusion 230, vacuum cavity 227 and needle guide 234,and the implant-forming solution within passage 100 withdrawn by pullingback on plunger 124. The needle 96 is cleansed with DMSO by filling theneedle passage 100 with DMSO from syringe 128 and thereafter withdrawingthe DMSO from the passage 100. After the subsequent priming needlepassage 100 with saline solution from syringe 128, the physicianpositions overtube assembly 42 within the gastrointestinal tract so thatthe desired recess 227 is disposed against the desired portion of wall232. Insertion tube distal extremity 54 b is then positioned withinovertube assembly 42 such that needle 96 aligns with the needle guide234 corresponding to such cavity 227 and the procedure discussed aboveis repeated thus creating one or more additional implants 229. Thephysician may rotate probe 44 with insertion tube 54 with respect toovertube assembly 42 to align needle 96 with the desired needle guide234, such as second needle guide 234′ shown in FIG. 6 if vacuum cavity227′ is positioned against the portion of wall 232 to be treated.

[0106] The number and configurations of implants 229 formed in wall 232can vary. Specific examples of implant configurations are disclosed inco-pending U.S. patent application Ser. No. 09/286,245 filed Apr. 5,1999. For example, a plurality of circumferentially spaced-apartimplants (not shown) may be created in wall 232 below lower esophagealsphincter 242 and below squamocolumnar junction 250. The implants may bedisposed substantially in a plane extending perpendicularly to alongitudinal axis extending along the centerline of esophagus 240 andinto the stomach 244. The implants may be also be substantially equallyspaced apart around the centerline, for example, at approximately 90°intervals in the case of four implants. It should be appreciated,however, that less than four or greater than four implants can beprovided and can be circumferentially spaced apart at approximatelyequal angular intervals or asymmetrically disposed about the centerline. The plane of implants can be disposed above, below and/or at thelower esophageal sphincter 242.

[0107] In other embodiments, implants can be formed which are notdisposed in a single plane. Furthermore, the sizing, spacing andconfiguration of implants determines whether the esophagus is augmentedor partially or completely coapted. A plurality of implants may also beformed in additional planes spaced apart from a first plane of implants.Such an array of implants can be longitudinally centered on thesquamocolumnar junction. In another embodiment, a single implant can beprovided for augmenting or partially or completely coapting esophagus inthe vicinity of the lower esophageal sphincter.

[0108] It should be appreciated that one or more implants can be formedin portions of the wall other than the mucosal layers. For example, oneor more implants can be formed in one or both of or between the musclelayers 252 and 254. Such implants can serve to augment or partially orcompletely coapt the esophagus in the vicinity of the lower esophagealsphincter and can also serve to reduce the distensibility of the musclelayers. Implants formed within or between muscle layers 252 and 254 canbe arranged in a variety of configurations, including any of the variousconfiguration of implants described above.

[0109] The implants created by the apparatus of the invention can addbulk to wall 232 so as to form a barrier between the stomach and theesophagus and/or, if introduced into one or both of the muscle layers252 and 254 of the wall 232, can serve to reduce the distensibility ofsuch muscle layers 252 and 254 and thereby increase the resistance ofthe wall 232 in the vicinity of the lower esophageal sphincter 242.Implants can also be formed in wall 232 to form a valve-like mechanismas disclosed in copending U.S. patent application Ser. No. 09/447,663filed Nov. 23, 1999, the entire content of which is incorporated hereinby this reference.

[0110] Although the method of the invention has been described asincluding the formation of a space 262 by a saline solution injectedinto the wall 232 prior to an injection of implant-forming solution intowall 232, it should be appreciated that space 262 can be formed by otheraqueous or physiologic solutions or by a local anesthetic. It is alsonoted that injection of an aqueous or other solution prior to injectionof the implant-forming solution is not essential. It is within the scopeof the present invention, for example, to inject the implant-formingsolution directly into the protrusion 230 without the prior formation ofa space 262 by an injection of saline solution or otherwise. Theimplant-forming solution can also be injected directly into wall 232without an injection of saline or any other solution for any secondarypurpose described herein or otherwise. A saline or other aqueous orphysiologic solution can optionally be introduced into such a spaceformed by the implant-forming solution, that is after the introductionof the implant-forming solution into wall 232, to facilitate dispersionof the DMSO or other biocompatible solvent present in theimplant-forming solution. It can thus be seen that the invention isbroad enough to cover the introduction of any conditioning solution intothe tissue before, during or after the treatment to facilitate thetreatment.

[0111] In an alternative method for forming a plurality of implantswithin wall 232, a plurality of spaces 262 can be formed by salinesolution from syringe 128. Subsequently, the implant-forming solutionfrom syringe 118 can be sequentially injected into each of such spaces.

[0112] It should be appreciated that the implants of the presentinvention can be used as delivery vehicles for other materials such asradioisotopes, chemotherapeutic agents, anti-inflammatory agents and/orantibiotics. In addition, treatment device 40 can be used for formingimplants from other suitable materials in wall 232 of a body. Suchmaterials include suitable suspensions such as injectable bioglass ofthe type described in Walker et al., “Injectable Bioglass as a PotentialSubstitute for Injectable Polytetrafluorethylene Particles”, J.Urol.,148:645-7, 1992, small particle species such as polytetrafluoroethylene(PTFE) particles in glycerine such as Polytef®, biocompatiblecompositions comprising discrete, polymeric and silicone rubber bodiessuch as described in U.S. Pat. Nos. 5,007,940, 5,158,573 and 5,116,387to Berg and biocompatible compositions comprising carbon coated beadssuch as disclosed in U.S. Pat. No. 5,451,406 to Lawin. Such suitablematerials for forming implants further include collagen and otherbiodegradable material of the type disclosed in U.S. Pat. No. 4,803,075to Wallace et al. and other known injectable materials.

[0113] The optional contrast agent in the implants permits the implantsto be monitored after completion of the procedure described above. Thusthe stability of the implant and its configuration can be observed overtime. Further procedures can be performed to supplement previouslyformed implants.

[0114] The apparatus for use with the implant-forming solution describedabove can be used in other gastrointestinal procedures for other thanthe treatment of gastroesophageal reflux disease and be within the scopeof the present invention. For example, the apparatus can be used toaugment luminal walls in the vicinity of fistulas to aid in the stentingor other treatment of fistulas as disclosed in copending U.S. patentapplication Ser. No. 09/286,531 filed Apr. 5, 1999, the entire contentof which is incorporated herein by this reference. The apparatus alsohas applications for the treatment of veins and arteries as disclosed incopending U.S. patent application Ser. No. 09/412,105 filed Oct. 4,1999, the entire content of which is incorporated herein by thisreference. In this regard, a modified apparatus could be used to injecta solution into veins in the lower esophagus to treat esophageal varicesand into veins in the vicinity of ulcers to treat for example gastriculcers. In addition, similar apparatus can be used to bulk other musclesin a body such as muscles in the vicinity of the anal sphincter to treatincompetent anal sphincters as disclosed in copending U.S. patentapplication Ser. No. 09/286,245 filed Apr. 5, 1999, the entire contentof which is incorporated herein by this reference. Similarly, theapparatus can be used for the treatment of hemorrhoids.

[0115] The present invention encompasses a minimally invasive apparatusto shape a portion of a wall forming a cavity in a body to be treated,that is to shape targeted tissue of the wall for injecting a materialtherein. Vacuum cavities 227 advantageously allow a physician to shapethe target tissue into protrusions 230 and form implants 264 in theprotrusions which have a consistent and predetermined size and shape.The ability to provide consistently sized and shaped implants 264contributes to the repeatability of the procedure.

[0116] It is noted that needle 96 can be provided with a plurality oflumens or passages (not shown) extending longitudinally therethrough forpermitting multiple liquids to be separately carried by the needle. In afurther alternative embodiment, a plurality of needles (not shown) canbe introduced through the working channels of a suitable probe such asprobe 44. Each of the needles can be used in combination with anovertube assembly in accordance with the invention. For example,separate needles can be provided for the introduction of the salinesolution or other physiologic or aqueous solution, for the introductionof the DMSO or other biocompatible solvent, and for the introduction ofthe implant forming solution into a protrusion 230 formed in a portionof the wall 232 of the gastrointestinal tract. In yet a furtheralternative embodiment, a plurality of needles in a single needleassembly can be introduced through a single working channel (not shown)of probe 54. The inclusion of multiple needles reduces the complexity ofthe procedure because the implant forming solution and saline solutionare no longer introduced through the same needle. Thus, for example, theDMSO priming step may be eliminated.

[0117] The structure of the overtube assembly and the probe may vary andbe within the scope of the present invention. In another embodiment, aplurality of needles may be provided in either the insertion tube and/orthe overtube assembly. For example, a modified overtube assembly 266which includes four needles 268,269,270 and 271 as shown in FIGS. 8-11.Overtube assembly 266 has proximal and distal extremities 266 a and 266b and is similar to overtube assembly 72; like reference numerals havebeen used to describe like components of overtube assemblies 72 and 266.Overtube assembly 266 has an overtube member 276 which is substantiallysimilar to overtube member 72 and an end cap 280 mounted on the distalend of the overtube member 276. The proximal end of end cap 280 isprovided with an annular recess 282 for receiving the distal end of theovertube member 276 (see FIG. 9). End cap 280 may be attached to theovertube member 276 by any suitable means such as an adhesive or heatshrinking or by means of a pressure fit, snap fit or screw fit. The endcap 280, like end cap 74, is provided with at least one and as shown aplurality of four circumferentially spaced-apart recesses 227 formed bybase 229 and peripheral wall 231. A plurality of apertures 228 areformed in a pattern on base 229 and extend therethrough forcommunicating the vacuum cavity 227 with internal chamber 68 of overtubemember 276 by means of passageways (not shown). End cap 280 can beformed integral with overtube member 276, like end cap 74 discussedabove, and be within the scope of the present invention.

[0118] Each of needles 268-271, which are preferably slidably disposedwithin respective sleeves 98 (not shown), extends through a respectivepassageway or lumen 272 located in side wall 274 of overtube member 276(see FIG. 10). The needles each enter the respective lumen 272 through aneedle port 273 located in the proximal end 266 a of overtube assembly266, as shown in FIG. 8. Although the four needle ports 273 are shown inFIG. 8 to be asymmetrically spaced apart in close proximity to eachother, one should appreciate that overtube assembly 266 can be providedwith a varying number of needle ports which can be asymmetrically orsymmetrically spaced about proximal end 266 a. Side wall lumens 272extend through side wall 274 of overtube member 276 and terminate inrespective vacuum cavities 227 (see FIG. 11). The four lumens 272 areangularly spaced apart about a longitudinal axis of overtube member 276at distal extremity 266 b to correspond to the respective vacuumcavities 227. In the embodiment of FIGS. 8-11, proximal end 266 aincludes a conventional fitting which direct needles 268-271 from theasymmetrically spaced-apart ports 273 to the symmetrically spaced-apartlumens 272 provided in side wall 274 of the overtube member 276. Needles268-271 are preferably provided with equal lengths, although the needles268-271 can having varying lengths as shown in FIG. 12. FIG. 10 showslumens 272 symmetrically spaced around the longitudinal axis of overtubemember 276, but it should be appreciated that lumens 272 may beasymmetrically spaced about the longitudinal axis.

[0119] Needles 268-271 of varying lengths, as shown schematically inFIG. 12, can be provided to assist the operating physician inidentifying the individual the needles within the body. For example, alonger needle may be provided at a relative twelve o'clock position anda shorter needle may be provided at a relative three o'clock position,such positions being readily discernable by the physician when theneedles are inserted equally into apparatus 40. Alternatively, theneedles may be differently colored or provided with other indicia toassist in their respective identification. Needles of various lengthsmay be used in combination with an identifying mark to assist inidentifying the needles within the body and to determine their relativeposition with respect to the overtube. Such an identifying mark 236,shown in FIG. 3, provides a position within the overtube assembly 42from which the position of a needle can be ascertained. With respect toFIG. 10, for example, needle 270 could be positioned at the twelveo'clock position adjacent the identifying mark, not shown in FIG. 10,and thus needle 271 would be positioned at the three o'clock position,needle 268 at the six o'clock position, and needle 269 at the nineo'clock position. The lengths of the extensions of the needles as theyare oriented at distal end 276 b of overtube member 276 clarify theirspatial position when viewed with reference to the identifying marklocated within overtube assembly 266. It should be appreciated that anovertube assembly having needles of various lengths and/or colors can beprovided without an identifying mark.

[0120] The use and operation of the embodiment of FIGS. 8-12 is similarto that of the first embodiment discussed above. For example, overtubeassembly 266 is of a length such that when distal end portion 266 b isin the vicinity of the lower esophageal sphincter, proximal end portion266 a is outside the body allowing the physician to manipulate needles268-271. The provision of several needles is advantageous in that aseparate needle may be dedicated to each vacuum cavity 227 thuseliminating the need to successively align a probe needle with acorresponding needle guide of several vacuum cavities.

[0121] In another embodiment, shown in FIGS. 13 and 14, overtube member274 includes pairs of parallel lumens which together terminate in arespective vacuum cavity 227. More specifically, overtube member 276therein has pairs of lumens 272, 272′ which extend through side wall 274in parallel and terminate in a single vacuum cavity 227. A pair ofneedles 278, 278′ extends through a corresponding pair of lumens 272,272′ and are insertable into the corresponding vacuum cavity 227, asshown in FIG. 14. An advantage of this embodiment is that each needlemay be dedicated to a single solution, thus eliminating the need tore-prime the needles. For example, needle 278 may be dedicated to thesaline solution in syringe 128 and needle 278′ may be dedicated to theDMSO in syringe 126.

[0122] In a further embodiment, an overtube assembly 283 having a singlevacuum cavity 284 can be provided. Overtube assembly 283, shown in FIG.15, is substantially similar to overtube assembly 266 and like referencenumerals have been used to describe like components of overtubeassemblies 266 and 283. An overtube member 285, similar to overtubemember 276, and an end cap 286 are included in assembly 283. End cap 286can be formed by any suitable means, such as injection molding, and ispreferably made from an optically clear material. The end cap 286 has alength ranging from one to ten centimeters and preferably ranging fromone to three centimeters and is secured to overtube member 285 by anysuitable means such as an adhesive (not shown). The end cap has an outercylindrical wall, in which single recessed portion or recess 284 isformed, and is provided with a longitudinally-extending lumen 287 whichcommunicates with sidewall lumen 272 of overtube member 285. Lumen 287terminates in vacuum cavity 284, which is formed by a base 288 and aperipheral wall 289. A plurality of passageways or apertures 290 extendthrough base 288 and communicate with internal chamber 68 of theovertube assembly 283. The apertures 290 are arranged in a pattern offour longitudinally-extending rows with two apertures in each row. Aneedle 96 with a protective sleeve 98 extends through lumens 272 and 287and is accessible at the proximal extremity of overtube assembly formovement into and out of the vacuum cavity 284. End cap 286 is formedwith a blunt, rounded nose 291 that is closed.

[0123] As discussed above with respect to end cap 74, the opticallyclear material of end cap 286 enhances visualization by permittingillumination of the esophagus with light guides 82. Such light enhancesthe clarity of the image received by optical viewing device 48. Therelatively short length of the end cap 286 and the relatively largediameter of pressure chamber 68 distal of insertion tube 54 permitoptical viewing device 48 to have a relatively large field of viewlooking distally of the end cap 286. The shape of the end cap nosecontributes to the type of image available to viewing device 48. In theembodiment of FIG. 15, rounded, convex nose 291 magnifies the imageviewed by optical device 48.

[0124] The end cap of the present invention may be formed of multiplecomponents. In the embodiment illustrated in FIG. 16, an end cap 292 isprovided that is mountable in the manner discussed above with respect toend cap 280 to an overtube member similar to those discussed above.Alternatively, end cap 280 can be a separate piece, like end cap 332discussed below, that is removably mounted to insertion tube 54 by anysuitable means such as discussed below with respect to end cap 332. Endcap 292 has a cylindrical sleeve member 294 in which at least one and asshown a plurality of openings 297 are formed for providing an equalplurality of vacuum recesses 297 in the end cap. Sleeve member 294receives an inner cylindrical portion 302 of an end piece 298.Cylindrical portion 302 serves as the base for the vacuum recesses orcavities 297 of end cap 292. Vacuum apertures 304 are formed within andextend through cylindrical portion 302 for providing suction to vacuumcavities 297. A needle guide 306 extends radially outwardly from innercylindrical portion 302 for each of the vacuum cavities and is formedwith an opening 307 extending therethrough for guiding the respectiveneedle 96 and sleeve 98 carried within insertion tube 54 toward vacuumrecess 296.

[0125] In the operation of end cap 292, shown in FIG. 17, a protrusion230 is formed in a vacuum cavity 297 in the manner discussed above. Theoperating physician then extends needle 96 into the protrusion to forman implant 264 and thus treat wall 232. The protrusion 230 can bevisualized with optical viewing device 48 during needle injection.

[0126] It should be appreciated that the vacuum cavity described hereinmay take the form of different shapes or geometries in order to formprotrusions of various desired shapes or geometries. An end cap 309, forexample being substantially similar to any of the end caps 74, 280 or286 described above, can be provided With one or more recesses or vacuumcavities 308 that are substantially semispherical in shape (see FIG.18). Like reference numerals have been used to describe like componentsof end caps 74, 280, 286 and 309. Each of the openings or recesses 308is substantially circular in cross section and is formed by a wall 310that is substantially circular in cross section. An array of openings311 are provided in wall 310 of each recessed portion or vacuum cavity308. The openings 311 communicate with a vacuum source (not shown) bymeans of a passageway or lumen (not shown) provided in the end cap 309.A needle (not shown), for example similar to needle 96 described above,is insertable into each of the vacuum cavities 308 by means of apassageway or needle guide 312.

[0127] In a further embodiment, an end cap 313 having at least onerecess or vacuum cavity 314 that is elongated or elliptical can beprovided (see FIG. 19). End cap 313 is substantially similar to end cap309 and like reference numerals have been used to describe likecomponents of end caps 309 and 313. As shown, a plurality of vacuumcavities 314 are provided in end cap 313. Each of theelliptically-shaped vacuum cavities is formed by a substantially planarbase 315 and a peripheral side wall 316 that is substantially ellipticalin shape.

[0128] An overtube assembly 317 substantially similar to overtubeassembly 42 is shown in FIG. 20, where like reference numerals have beenused to describe like components of overtube assemblies 42 and 317. Theovertube assembly has an end cap 318 secured to the distal end ofovertube member 72, which end cap 318 is more particularly shown asbeing formed integral with the overtube member 72. At least one and asshown a plurality of recesses or vacuum cavities 319 are formed in theouter cylindrical wall of end cap 318. More specifically, overtubeassembly 317 has a plurality of four vacuum cavities 319circumferentially spaced apart about the longitudinal axis of theovertube assembly 317 at equal separation angles of 90°. Each of thevacuum cavities is formed by an arcuate, concave wall 320, that gentlycurves substantially the entire length of the vacuum cavity, so as tohave a shape which resembles half of a teardrop.

[0129] The operation and use of overtube assembly 317 is similar to theprocedure discussed above with respect to overtube assembly 42. Afterovertube assembly 317 and probe 54 have been properly positioned withinthe gastrointestinal tract with one of the vacuum cavities 319 disposedadjacent the targeted tissue, suction source 220 is activated by theoperating physician to provide a negative pressure in chamber 68 andeach of vacuum recesses 318 and thus draw a portion of wall 232 into thedesired vacuum cavity 319. A protrusion 230 is thereby formed in suchvacuum cavity that has substantially the shape of the vacuum cavity (seeFIG. 20). Needle 96 is inserted through the respective needle guide 234and into the vacuum cavity to penetrate the protrusion 230 and form animplant within the protrusion. Needle 96 is shown penetrating circularmuscle layer 252 in FIG. 20, prior to the injection of theimplant-forming solution into the protrusion. The arcuate shape ofrecess wall 320 influences the cross-sectional shape of the implant soformed in wall 232.

[0130] As can be seen, differently shaped vacuum cavities or recessescan be used to form protrusions 230 of various shapes. For example,cavity recess 308 shown in FIG. 18 can be used to form a substantiallysemispherical-shaped protrusion and thus a similarly shaped implant. Itshould be appreciated from the foregoing that a multitude of othercavity shapes and profiles may be used in accordance with the presentinvention. For example, other end caps can be provided with one or morevacuum recesses having the shape of a square or rectangle.

[0131] Apparatus of the present invention can also be provided withvacuum cavities that extend circumferentially around the distal portionof the apparatus. The distal portion of an overtube assembly 321,substantially similar to overtube assembly 42, is shown in FIGS. 21 and22. Like reference numerals have been used in FIGS. 21 and 22 todescribe like components of overtube assemblies 42 and 321. The overtubeassembly 321 has an end cap 322 secured to the distal end of overtubemember 72 by any suitable means. At least one and as shown a singlerecess or vacuum cavity 323 is formed in the outer cylindrical wall ofend cap 322. The recessed portion or vacuum cavity 323 extendscircumferentially an angle of 360° about the longitudinal axis ofovertube assembly 321, as shown in FIG. 21 and is formed by asemicircular-shaped wall 324. A plurality of circumferentially-disposedvacuum apertures 326 extend through wall or recess base 324. The vacuumapertures 326 are radially extending and circumferentially spaced aroundthe longitudinal axis of overtube assembly 324 to fluidly connectcircumferential recess 323 with pressure chamber 68 by means of centralbore 223 to provide suction to the recess 323. Needle 96 is insertableinto a selected portion of vacuum cavity 323 by means of a plurality ofcircumferentially-disposed bores or needle guides 330 which extend fromthe distal end of internal chamber through the proximal portion ofrecess wall 324.

[0132] In the operation of overtube assembly 321, a portion of the wall232 to be treated is drawn into circumferential vacuum recess 323 assuction source 220 is activated. Such portion of wall 232 cansubstantially assume the shape of circumferential vacuum recess 323 soas to form at least a partial arcuate or circumferential protrusion,such as an arcuate protrusion of the type disclosed in U.S. patentapplication Ser. No. 09/447,663 filed Nov. 23, 1999. Needle guides 330assist in guiding needle 96 into circumferential vacuum recess 323 aswell as any protrusion formed therein. Although a single injection witha single needle 96 can be utilized for forming an implant in the portionof wall 232 drawn into vacuum cavity 323, in an alternate procedure aplurality of injections can be made by means of one or more needles 96.

[0133] Other circumferential recess geometries may also be used toprovide various protrusion and implant shapes. For example,circumferential vacuum recesses similar to vacuum cavity 323 can beprovided with any suitable profile such as any of the profiles or crosssections shown in FIGS. 18-20 in order to form circumferentialprotrusions of various desired shapes. One should appreciate that anarcuate vacuum recess can be provided that extends angularly about thelongitudinal axis of the overtube assembly less than the entirecircumference of the overtube assembly. For example, vacuum cavities canbe provided that extend approximately 90° or 180° around an overtubeassembly and be within the scope of the present invention.

[0134] In another embodiment of the present invention, as shown in FIG.23, a short tubular assembly or overtip assembly 332 is used incombination with a conventional probe such as insertion tube 54. Morespecifically, second member or overtip assembly 332 is removablyattached or mounted to distal end 54 b of insertion tube 54. As such,overtip assembly 332 does not extend along the length of insertion tube54 and, in use with the insertion tube, does not have a proximal portionaccessible outside of body 238. In this regard, overtip assembly 332 hasa length ranging from one to ten centimeters and preferably ranging fromtwo to three centimeters. Overtip assembly includes a cylindrical bodyor end cap 333 made from plastic or any other suitable material. The endcap 333 has a diameter ranging from 0.5 to 2.5 centimeters andpreferably ranging from 0.75 to 1.5 centimeters. Alongitudinally-extending internal chamber 334 is provided at theproximal extremity of end cap 333 and a central bore 335 extendsdistally from chamber 334 to an opening 391 at the distal end or end cap333. An optical window 392 similar to optical window 226 is sealablysecured to end cap 333 at opening 391. At least one and as shown onevacuum recess or cavity 393 is provided in the outer cylindrical surfaceof end cap 333. The recess or vacuum cavity 393 is formed in part by aplanar wall or base 394 and the cavity can have any suitable size andshape, including any of the shapes discussed above. A plurality of boresor apertures 395 extend through base 394 to fluidly connect the vacuumcavity 392 with central bore 335.

[0135] Means including a flexible tubular member or sleeve 397 isincluded in overtip assembly 332 for removably mounting end cap 333 todistal end 54 b of insertion tube or probe 54. Sleeve 397 is made fromany suitable material such as silicone, and is diametrically sized andhas sufficient elasticity to extend over a portion of distal end 54 andsecure thereto with a friction fit. The proximal end of end cap 333generally abuts distal end 54 b when overtip assembly 332 is so securedto the insertion tube 54. Sleeve 397 further serves as a seal and thusserves to provide a fluid-tight connection between insertion tube 54 andend cap 333. At least one longitudinally-extending bore or guide 398extends from the distal end of internal chamber 334 to the proximal endof vacuum cavity 393 for permitting a needle 96 carried by insertiontube 54 to be removably inserted into the vacuum cavity 393.

[0136] In operation and use, overtip assembly 332 is mounted on distalend 54 b of the insertion tube 54 prior to insertion of the tube 54 intothe body 238. Suction is provided to internal chamber 334 and thusvacuum cavity 393 by means of insertion tube when it is desired to drawa portion of wall 232 into the cavity 393. Needle 96, slidably carriedby insertion tube 54 and manipulable from outside of body 238, isinserted into the protrusion 230 formed in cavity 393 for injecting theimplant-forming solution into protrusion 230 and thus wall 232 in themanner discussed above.

[0137] A further embodiment of an apparatus for forming implants in thewall of a cavity within a body of a mammal is shown in FIG. 24. Theapparatus 337 therein includes insertion tube 54 and an overtip assembly338 substantially similar to overtip assembly 332 described above. Likereference numerals have been used in FIG. 24 to identify like componentsof overtip assemblies 332 and 338. An end cap 339 substantially similarto end cap 333 and a flexible attachment sleeve 334 are included in theovertip assembly 338. End cap 339 has a central passageway or bore 340extending longitudinally therethrough for permitting viewing withoptical viewing device 43 forwardly of the overtip assembly 338. Therelatively short length ofovertip assembly 332 facilitates forwardviewing by optical viewing device 48. Such forward viewing is furtherenhanced by forming central bore 340 with a relatively large diameter.Overtip assembly 338 does not include an optical window, such as opticalwindow 392, on the distal end of central bore 340. As a result, bore 340is not capable of providing negative pressure or suction to apertures395 and the vacuum cavity 393 of end cap 339.

[0138] External means is included in apparatus 337 for providing suctionto vacuum cavity 393 and includes an external suction tube 342 thatextends externally alongside insertion tube 54. Suction tube 342 has aproximal end 342 a connected to a conventional stop cock and fluidfitting assembly 343 for permitting the tube 342 to be connected in afluid-tight manner to a suitable suction source such as suction source220 described above. The suction tube has a distal end 342 b thatextends into end cap 339 and connects in a fluid-tight manner toapertures 395. External suction tube 342 can be secured alongsideinsertion tube 54 by any suitable means such as a small rubber sleeve344 concentrically disposed about insertion tube 54 to hold suction tube342 against its outer circumference.

[0139] Apparatus 337 further includes a multi-window overtube member 346which slidably extends over overtip assembly 338 and insertion tube 54for rotatable movement therewith. Overtube member 346 can be made fromany suitable material such as plastic and is provided with a centralpassageway 347 for slidably and rotatably receiving the overtip assemblyand insertion tube. The overtube member 346 has proximal and distalextremities 346 a and 346 b and has a length so that when the distalextremity 346 b is inside the desired cavity of the body, such as theupper gastrointestinal tract, adjacent the targeted tissue, the proximalextremity 346 a is outside of the body. A plurality and as shown aplurality of four circumferentially spaced-apart side openings 348 areformed in distal extremity 346 b. A distal or end opening 349 is furtherprovided in overtube member 346. Each of side openings 348 has a sizeand shape which approximates the size and shape of the opening of vacuumcavity 393 and is longitudinally positioned on the overtube member 346so that when the overtip assembly 338 abuts the end of the overtubemember 346, one of the openings 348 can be selectively registered withthe vacuum cavity 393. End opening 349 preferably has a size and shapeapproximating the size of central bore 340 of the overtip assembly 339for permitting forward viewing through the overtube member 346. A flangemember or handle 350 is formed on proximal extremity 346 a of overtubemember 346 for facilitating rotation of the overtube member aboutinsertion tube 54 and overtip assembly 338.

[0140] In operation and use, overtube member 346 serves to facilitaterotation of overtip assembly 338 and insertion tube 54 within the bodycavity, particularly where the overtube member is snugly disposed withinsuch body cavity. Where, for example, a probe is so snugly disposed in abody cavity, apposition of soft tissue to the probe can occur and thushinder rotation of the probe within the cavity. As a result, the abilityof the operating physician to desirably position the probe within thecavity may be limited. Overtube member 346, which has multiple sideopenings or windows 348, overcomes this disadvantage when used within anesophagus 240 by allowing the operating physician to adjust the positionof the overtube member 346 by rotating the overtube member 346 withinesophagus 240 or other body passageway once and then treat several areastherein by rotating insertion member 54 and overtip assembly 338 withinthe overtube member to one or more of the several positions in whichvacuum cavity 393 of the overtip assembly registers with a side window348 of the overtube member. Apposition of soft tissue to apparatus 337is reduced and/or eliminated because overtube member 346 is notrepeatedly rotated within the esophagus.

[0141] Overtip assembly 338 is provided with only a single vacuum cavity393. This advantageously enhances the suction forces exerted on theprotrusion formed in the vacuum cavity 393, in contrast to an overtubeassembly or overtip assembly in which only one of multiple vacuumcavities is engaging wall 232 and thus the remainder of the vacuumcavities are open within the gastrointestinal tract thereby reducing thevacuum force capable of being supplied by the common suction source tothe selected vacuum cavity. A dedicated vacuum supply is provided tosingle cavity 393 by means of external suction tube 342. As discussedabove, vacuum cavity 393 is registerable with the desired side opening348 in overtube member 346 during operation.

[0142] Forward visualization is optimized by means of foreshortenedovertip assembly 338, large diametered central bore 340 in the overtipassembly and the unobstructed openings at the distal ends of the overtipassembly 338 and the overtube member 346.

[0143] In other embodiments, apparatus can be provided having means forurging the vacuum recess against the targeted wall portion for enhancingformation of implants in the wall. For example, apparatus 351 shown inFIG. 25 has urging means in the form of a balloon. Apparatus 351 has anovertip assembly 352 substantially similar to overtip assembly 332. Likereference numerals have been used in FIG. 25 to identify like componentsof overtip assemblies 352 and 332. The overtip assembly 352 is mountedon distal end 54 b of insertion tube 54 by any suitable means such asflexible sleeve 397.

[0144] An inflatable balloon 353 is carried within a recess 354 providedon end cap 339 generally opposite vacuum cavity 393. An externallymounted air feeding or air supply tube 355 is provided to inflateballoon 353. Supply tube 355 has a proximal end 355 a connected to aconventional stop cock and fluid fitting assembly 399 for permitting thetube 355 to be connected in a fluid-tight manner to a suitable fluidinflation supply (not shown). The supply tube has a distal end 355 thatextends into end cap 339 and connects in a fluid-tight manner to balloon353. Air supply tube 355 may be mounted externally on insertion tube 54in the same manner as suction tube 342 discussed above, for example bymeans of rubber sleeve 344. Alternatively, an air or inflation fluidtube internal of insertion tube 54 can be provided for inflating balloon353.

[0145] In operation and use, balloon 353 is used to bias or urgeinsertion tube 54 and overtip assembly 338 against the portion of wall232 to be captured within cavity 393 and implanted. Balloon 353facilitates placement of vacuum cavity 393 against wall 232 and thecreation of suction within the vacuum cavity by pressing end cap 339against the opposite portion of the wall of the esophagus or other bodypassageway being implanted. Balloon 353 can be used independent ofsuction source 220 or used in conjunction with suction source 220 tourge the targeted portion of the wall of the esophagus or other bodypassageway into implantation cavity 393 for injection by needle 96. Itshould also be appreciated that a balloon such as balloon 353 can beprovided in any of the embodiments of the invention discussed above.

[0146] When balloon 352 is used in conjunction with suction source 220,an externally mounted suction tube 342 and air supply tube 355 may beprovided. In one embodiment, an externally mounted dual lumen tube maybe provided in which one lumen of the tube is fluidly connected tovacuum cavity 393 for providing suction thereto and the other lumen ofthe tube is fluidly connected to balloon 355 for supplying air thereto.

[0147] A kit 356 for use in forming a protrusion in a wall and treatingthe wall forming the upper portion of a gastrointestinal tract in ahuman body in accordance with the method of the present invention isshown schematically in FIG. 26. Kit 356 includes a package 358 made fromany suitable material such as cardboard or plastic for carrying thecontents thereof. An exemplary package 358, shown in FIG. 26, is a boxformed from a bottom wall 360, four side walls 362 and a top wall 364. Aportion of top wall 364 is cut away in FIG. 26 to reveal an internalspace 366 formed by walls 360, 362 and 364. The contents of receptacleor package 358 are disposed in internal space 366.

[0148] Needle assembly 52 is carried by package 358 within internalspace 366. As discussed above, needle assembly 52 includes a needle 96within a sleeve 98 and a fluid connector 110. A cap 368 is removablyattached to distal end portion 98 b of the sleeve 98 for protectingusers against undesirable punctures by needle distal end portion 96 bduring storage and setup. Luer fitting portions 114 and 116 of fluidconnector 110 are shown as being capped in FIG. 26. Kit 356 furtherincludes reservoir or syringe 118 and a container or vial 370 of anysuitable implant forming solution. In one preferred embodiment, theimplant forming material is the nonaqueous implant-forming solutionreferred to above. Vial 370 has a needle-penetrable cap 372 and Luerfitting portion 122 of syringe 118 is attached to a standard hypodermicneedle 373, optionally included within kit 356, that is removablycoupled to cap 372 by penetrating the cap 372 for loading the syringe118. As discussed above, Luer fitting portion 122 of the syringe 118 isalso removably coupled to fluid connector 110 of needle assembly 52.

[0149] A tubular assembly, such as overtip assembly 332, is includedwithin kit 356 for forming protrusions in gastrointestinal walls asdiscussed above. Although overtip assembly 332 is shown in FIG. 26, kit356 may include longer overtube assemblies, such as overtube assembly 42shown in FIGS. 1-3, instead of or in addition to overtip assembly 332.Kit 356 can also optionally include a suitable suction source 220, shownin FIG. 26 as being a syringe, for producing a negative pressure withinthe pressure chamber and vacuum recesses 393 of end cap 333.

[0150] A delivery mechanism such as gun 150 for supplying a plurality ofdiscrete preselected amounts of the nonaqueous solution from syringe 118can optionally be included within kit 356. Syringe 118 is shown in FIG.26 as being mounted within gun 150. Additional optional components ofkit 356 include a second reservoir, such as syringe 126, and a containerof a biocompatible solvent such as DMSO in the form of vial 374. Vial374 includes a needle-penetrable cap 376 and syringe 126 has a Luerfitting portion 378 that is attachable to a standard hypodermic needle377, optionally included in kit 356, that is removably coupled to cap376 of the vial 374. Kit 356 can optionally further include a pluralityof stopcocks, such as stopcocks 132, 134, 136 and not shown in FIG. 26,for forming a manifold assembly 130 suitable for selectively directingthe flow of liquid through needle assembly 52 in the manner discussedabove. A third reservoir or syringe (not shown) and/or a vial of aqueoussolution such as saline solution (not shown) can also be optionallyincluded in kit 356.

[0151] Kit 356 can be used in any of the procedures described above orin any other procedure for treating wall 232 in the uppergastrointestinal tract. Needle assembly 52 of the kit 356 is preferablyused with a probe device such as probe 44 described above with referenceto FIGS. 1-3, 6 and 7. In this regard, needle assembly 52 isdiametrically sized for introduction into the gastrointestinal tractthrough probe 44 and, more particularly, through working channel 88 ofprobe insertion tube 54. Syringe 118 is loaded with the nonaqueoussolution from vial 331 by any suitable means such as coupling Luerfitting portion 122 of the syringe 118 to hypodermic needle 373 forpenetrating cap 332 of the vial 330. When filled, syringe 118 isattached to fluid connector 110 in a manner discussed above. Probe 44 isintroduced into esophagus 240 until distal extremity 54 b of insertiontube 54 is in the vicinity of the treatment area. Thereafter, distal endportions 96 b and 98 b of needle assembly 22 are advanced throughinsertion tube 54 until such distal end portions of needle 96 and sleeve98 are in the vicinity of insertion tube distal extremity 54 b.

[0152] When gun 150 is so used, syringe 118 is mounted within the gun ina manner discussed above. In addition, optional syringe 126 can be usedfor supplying a suitable biocompatible solvent such as DMSO throughneedle assembly 52 during the procedure. The syringe 126 is filled byremovably coupling Luer fitting portion 378 thereof to hypodermic needle377 for penetrating cap 376 of vial 374. Thereafter, the syringe 126 iscoupled to fluid connector 110 in a manner discussed above. In addition,optional saline solution syringe 128 can be coupled to fluid connector110 in a manner discussed above for use during the procedure.

[0153] Overtip assembly 332 can be mounted on distal end 54 b ofinsertion tube 54 for facilitating the creation of implants in thetargeted wall of the body 238.

[0154] Kit 356 can be used for treating tracheo-esophageal fistulas,veins and arteries and gastric ulcers in the manner described above. Kit356 can also be used in any other procedure within the uppergastrointestinal tract or other suitable cavity within a body where itis desired to form implants in the wall of the gastrointestinal tract orsuch cavity.

[0155] A further embodiment of the treatment device of the presentinvention is shown in FIGS. 27-29. The portion of the treatment deviceshown therein includes an additional member or short overtip assembly411 for use with insertion probe 54. Overtip assembly 411 is similar toovertip assembly 332 described above and includes an end piece or endcap 412 made from any suitable hard plastic such as PMP or acrylic. Theend piece 412 is preferably optically clear. End piece 412 has proximaland distal extremities 412 a and 412 b centered on a longitudinal axisand has a length ranging from one to ten centimeters and preferablyranging from one to three centimeters.

[0156] Distal extremity 412 b of the end piece is formed from an outercylindrical wall 416. At least one recessed portion or recess 417 isprovided in overtip assembly 411 and, as shown in FIGS. 27-29, a singlerecess 417 is formed in outer cylindrical wall 416 of the distalextremity 412 b. The recess 417 is cup-shaped and formed from a basewall or base 418 and a peripheral wall or rim 419. End piece 412 has ablunt nose 422 formed by the distal end of peripheral wall 419. A planarwall in the form of optics window 423 extends at an oblique angle to thelongitudinal axis of the end piece from blunt nose 422. Window 423 isdisposed substantially opposite recess 417 and extends below the recess417.

[0157] Means is included in overtip assembly 411 for removably mountingend piece 412 to the distal end of a probe such as insertion tube 54.Such means includes a sleeve 426 substantially similar to sleeve 397 andmade from any suitable material such as silicone. The tubular sleeve 426has an internal diameter that is sized to snugly receive the distal endof insertion tube 54. Proximal extremity 412 a of end piece 412 isannular in conformation and diametrically sized relative to sleeve 426to snugly receive the distal end of sleeve 426 thereover. Sleeve 426thus serves to secure end piece 412 to insertion tube 54 as well asprovide a fluid tight seal between the end piece and the insertion tube.

[0158] An internal chamber or passageway 431 is provided inside thehollow end piece 412. A plurality of passageways or openings 432 extendthrough the base 418 of recess 417 for providing fluid communicationbetween internal chamber 431 and the recess 417. Although openings 432can be of any suitable size and shape, the openings 432 are shown asincluding a plurality of slots 432 a extending across base 418substantially perpendicular to the longitudinal axis of overtip assembly411 and a large opening 432 b formed below rim 419 at the proximal endof the recess 417.

[0159] End piece 412 is provided with a needle guide 433 for directing aneedle slidably carried within insertion tube 54, such as needle 96shown in FIG. 27, into the proximal end of recess 417. The needle guidedepends from the annular wall of end piece proximal extremity 412 a andextends from the opening at the proximal end of internal chamber 431into recess 417 by means of the large proximal opening 432 b. Needleguide 433 has a bore 434 which extends from the proximal end of endpiece 412 into the recess 417. The proximal end of the bore 434 isflared for facilitating the capture of needle 96 by guide 433.

[0160] In operation and use, overtip assembly 411 can be removablymounted on the distal end 54 b of insertion tube 54 by means of elasticsleeve 426. Distal extremity 54 b of the insertion tube is received bythe sleeve 426 and generally abuts proximal extremity 412 a of end piece412. The overtip assembly 411 and insertion tube 84 are introduced intothe appropriate cavity of the body, such as through the mouth into theesophagus, in the manner discussed above.

[0161] Overtip assembly 411 is advantageously sized and constructed soas to facilitate its advancement into and through the esophagus and thetreatment of the desired portion of the esophageal wall 232. Therelatively short length of end piece 412 permits the overtip assembly411 to be easily navigated through the entrance of the esophagus,particularly in the vicinity of the vocal chords. The optically clearmaterial of the end piece contributes to the illumination, by lightguides 82, and resulting clarity of the wall 232. Forward viewing withminimal distortion is permitted by planar window 423. The relativelyshort length of end piece 412 as well as the relatively large transversedimension of internal chamber 431 provide optical viewing device 48 witha relatively large field of view.

[0162] After proper placement of the overtip assembly 411 within theesophagus, suction from source 220 is provided to recess 417 by means ofslots 432 a and proximal opening 432 b. The desired portion of wall 232to be treated is pulled into recess 417 by such suction, with slots 432a pulling the tissue against the base of the recess 417 and proximalopening 432 b pulling the tissue up against the distal end of needleguide 433 at the proximal end of recess 417. Thereafter, needle 96 isadvanced from insertion tube 54 through needle guide 433 into theprotrusion 230 (not shown) formed within recess 417 so as to permit oneor more implants to be formed in the protrusion in the manner discussedabove. The taut retention of the protusion in the recess 417 by openings432 facilitates the repeatable formation of similar implants. Thepositioning of insertion tube distal extremity 54 b relative to endpiece 412 and the relatively large transverse dimension of internalchamber 431 permit the optical viewing device 48 to easily view needle96 being introduced into recess 417 and the protrusion 230 to be formedtherein.

[0163] As can be seen from the foregoing, a minimally invasive apparatushas been provided for injecting a material into a portion of a wallforming a cavity in a body, such as the gastrointestinal tract, to formone or more implants of a substantially consistent size in the wall. Arecess in a probe is utilized to shape the portion of the wall into aprotrusion into which the material is injected. The probe guides andpositions an injection needle into the protrusion. Consistently sizedmultiple implants may be formed in a portion of the wall of the cavity.The probe inhibits the injection need from being pushed through the wallof the cavity. The apparatus and procedure can be utilized for treatinggastroesophageal reflux disease.

[0164] The foregoing descriptions of specific embodiments of the presentinvention have been presented for purposes of illustration anddescription. They are not intended to be exhaustive or to limit theinvention to the precise forms disclosed, and obviously manymodifications and variations are possible in light of the aboveteaching. The embodiments were chosen and described in order to bestexplain the principles of the invention and its practical application,to thereby enable others skilled in the art to best utilize theinvention and various embodiments with various modifications as aresuited to the particular use contemplated. It is intended that the scopeof the invention be defined by the claims appended hereto and theirequivalents.

1-28. (cancelled).
 29. A kit for use with an elongate probe memberhaving proximal and distal extremities to treat a wall forming the upperportion of a gastrointestinal tract in a body of a mammal comprising apackage, a tubular needle adapted for slidable disposition in theelongate probe member carried within the package and having proximal anddistal end portions, an end piece adapted to mount to the distalextremity of the elongate probe member carried within the package, theend piece having an outer surface and being provided with at least onerecess opening onto the outer surface and a container of animplant-forming material carried within the package whereby the endpiece is mounted on the distal extremity of the elongate probe memberand introduced into the upper portion of the gastrointestinal tractwhere a portion of the wall is drawn into the recess and whereby thetubular needle is extended into the portion of the wall in the recessand material is loaded into the tubular needle and injected into theportion of the wall to form an implant in the wall.
 30. The kit of claim29 wherein the implant-forming material includes a solution having abiocompatible polymer and a biocompatible solvent.
 31. The kit of claim30 wherein the solution of the biocompatible polymer and thebiocompatible solvent has a composition having from about 2.5 to about8.0 weight percent of a biocompatible polymer, from about 10 to about 40weight percent of a water insoluble biocompatible contrast agent andfrom about 52 to about 87.5 weight percent of a biocompatible solvent.32. The kit of claim 29 wherein the implant-forming material includes abiocompatible prepolymer whereby the prepolymer polymerizes in situ toform the implant in the wall.
 33. The kit of claim 29 wherein thecontainer further includes a contrast agent for facilitatingvisualization of the implant in the wall.
 34. The kit of claim 29wherein the end piece has an outer cylindrical surface and is providedwith a recess extending circumferentially around the outer cylindricalsurface.
 35. The kit of claim 29 wherein the end piece has an outercylindrical surface and is provided with a plurality ofcircumferentially spaced-apart recesses in the outer cylindricalsurface.
 36. A kit for use with an elongate probe member having proximaland distal extremities to treat a wall forming the upper portion of agastrointestinal tract in a body of a mammal comprising a package, atubular needle adapted for slidable disposition in the elongate probemember carried within the package and having proximal and distal endportions, an end piece adapted to mount to the distal extremity of theelongate probe member carried within the package, the end piece havingan outer surface and being provided with at least one recess openingonto the outer surface and an internal passageway communicating with therecess, a syringe removably couplable to the proximal end portion of thetubular needle carried within the package and a container of a solutionfor forming a nonbiodegradable solid in the wall carried within thepackage whereby the end piece is mounted on the distal extremity of theelongate probe member and introduced into the upper portion of thegastrointestinal tract where a portion of the wall is drawn into therecess and whereby the tubular needle is extended through the internalpassageway into the portion of the wall in the recess and solution isloaded by the syringe into the tubular needle and injected into theportion of the wall to form a nonbiodegradable solid in the wall. 37.The kit of claim 35 wherein the tubular needle has a length so that whenthe distal end portion is in the vicinity of the lower esophagealsphincter the proximal end portion is outside of the body.
 38. The kitof claim 35 wherein the solution includes a biocompatible polymer and abiocompatible solvent.
 39. The kit of claim 35 further comprising anadditional container of a biocompatible solvent carried within thepackage.
 40. The kit of claim 35 further comprising a delivery mechanismfor supplying a plurality of discrete preselected amounts of thesolution from the syringe to the tubular needle for introduction intothe wall.
 41. The kit of claim 35 wherein the solution includes abiocompatible prepolymer whereby the prepolymer polymerizes in situ toform the nonbiodegradable solid in the wall.
 42. The kit of claim 41wherein the solution includes a biocompatible solvent.
 43. The kit ofclaim 35 wherein the solution is a nonaqueous solution.
 44. The kit ofclaim 35 wherein the solution includes a contrast agent for facilitatingvisualization of the nonbiodegradable solid in the wall.
 45. The kit ofclaim 35 wherein the end piece has an outer cylindrical surface and isprovided with a recess extending circumferentially around the outercylindrical surface.
 46. The kit of claim 35 wherein the end piece hasan outer cylindrical surface and is provided with a plurality ofcircumferentially spaced-apart recesses in the outer cylindricalsurface.